About this deal
The company searched the Medicines and Healthcare Products Regulatory Agency (MHRA), Food and Drug Administration (FDA) and Manufacturer and User Facility Device Experience (MAUDE) systems to identify surveillance reports relating to Tegaderm CHG, between 7 January 2000 and 29 July 2013. This revealed 1 result from the MHRA and 109 results from MAUDE. The company also searched its post‑marketing surveillance data for reported skin reactions. This identified a marked reduction in reports, both in numbers and relative to increasing sales, after a modification to the dressing design in 2011 to incorporate a breathable film. The Cheyne Child Development Service - School age Autism (ASD) Assessment Pathway Parent Information
Then wrap a piece of gauze around it to make the clamps fit more securely this also prevents damage that the clamps can do to the central line. Lemmon JA, Janis JE, Rohrich RJ. Soft-tissue injuries of the fingertip: methods of evaluation and treatment. An algorithmic approach. Plast Reconstr Surg. 2008 Sep;122(3):105e-117e.The External Assessment Centre extended the company's search to 28 November 2014 and identified a further 17 results. These results generally described local skin reactions within 48 hours of dressing application, and many were self‑limiting. There were 2 deaths reported in MAUDE, but these were not directly linked to Tegaderm CHG.
The company proposed that using the 3M Tegaderm CHG IV securement dressing (Tegaderm CHG) would not result in changes to the current care pathway or need additional resources. The External Assessment Centre agreed with these assumptions. The External Assessment Centre agreed with including Timsit et al. (2012) and excluding the 4 remaining studies identified.The External Assessment Centre found that the company's search of the MAUDE and MHRA systems accurately reported, in detail, the adverse events for Tegaderm CHG. Overall, it considered the company's search for adverse events to be robust. Wrap a piece of occlusive dressing (e.g IV 3000) around the break, to ensure the line does not get dirty Should any of the above occur please take your child to their local hospital or call your community nurse for assessment.