SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (LARGE) PACK OF 10; DRESSING,WOUND,OCCLUSIVE
|
Back to Search Results |
|
Model Number 66801307 |
Device Problem
Loss of or Failure to Bond (1068)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/21/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that, it was noticed that the silicone is detached and remains on the protective plastic film.As a result, the bandage does not stick anymore.No case involved; therefore, there was no patient involvement.
|
|
Manufacturer Narrative
|
H3, h6: the devices, intended to be used in treatment, have been received for evaluation.A visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed that the dressing had reduced bonding capabilities, establishing a relationship between the device and the reported event.The root cause was identified as a raw material issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with further actions being taken relating to the failure reported.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
|
|
Search Alerts/Recalls
|
|
|