LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20
Received Apr 28, 2021 · Event occurred Apr 1, 2021
Report 8043484-2021-00985 · MDR key 11741621
Device
Generic name
Topical Approximation System
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66102872
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THIS PRODUCT IS NOT APPROVED IN THE US. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT ADHESIVE STRENGTH OF LEUKOSTRIP ASS 38X4MM 76X6.4MM CTN 20 WAS TOO LOW, THEREFORE PRODUCT IS NO RELIABLE. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED.