Method: the actual product involved with the incident was discarded.No samples or photos were returned for evaluation to date.Results/conclusions: no samples were returned for review.Relevant portions of the device history record were reviewed.The product from this finished good lot and all of the component lots met current usp and surgical specialties mexico inc.Requirements throughout the incoming, manufacturing and the final inspection processes.No inventory is available for the finished good lot reported.Without receiving samples to review/test, receiving detailed information regarding the surgeon's technique, material placement in tissue, pre-operative instructions or events a definitive root cause for the partial dehiscence cannot be determined with certainty.Infection was mentioned.However, no details or culture results were received to confirm this report.(b)(4).Item #sj493g mckesson pss 5-0 undyed pga 18" c3, lot mdlf410 (reading).
|
An epidermal cyst was fully excised on a patient with hypertention, dm, hyperlipidemia.When patient returned to have sutures removed, there was a yellow discharge from one corner of the wound and circumferential erythema.This persisted until sutures were removed.Wound dehiscence from the inside was noted.Pieces of suture were removed from the deep dermal tissue.No additional details were disclosed.
|