LEUKOCLIP SD HANDLE
Received Aug 19, 2020 · Event occurred Jul 23, 2020
Report 8043484-2020-02533 · MDR key 10424379
Device
Generic name
Topical Approximation System
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66047111
Lot number
887816
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE 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 THE HANDLES (SPRINGS) SPIKES DROP OUT OF DEVICES, HANDLES DON'T BEND THE SKIN STAPLERS ENOUGH, SO THE DOCTOR GETS STUCK WITH THE HANDLE AT THE PATIENTS HEAD SKIN WHICH CAUSES PAIN.