|
Model Number 66000016 |
Device Problems
Product Quality Problem (1506); Failure to Unfold or Unwrap (1669)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that, during treatment, in four boxes of profore 18-25cm ankle circ.Case 8, the 4th layer was very hard to pull out and to roll on patients¿ legs, the adhesiveness was very tight compares with other batches.It was also reported that the quality was not consistent, the diameter of this layer roll was different individually.It is unknown how treatment was completed.No harm to the patient or any further complications reported.
|
|
Manufacturer Narrative
|
H3, h6: the device, used in treatment, has not been returned for evaluation.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.A complaint history review was performed for the product and event description, there have been further instances of this nature.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.
|
|
Search Alerts/Recalls
|
|
|