MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number CON3006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Conclusion: the device was not returned for evaluation.Based on limited information, including no identification of the relevant lot number, a relationship between the event and the strattice could not be determined.Due to lack of information, strattice as a contributing factor cannot be ruled out.Lifecell reports the event in abundance of caution.Multiple attempts to obtain additional information are being made, including the identification of the lot number; however to date, no further information has been obtained.Should additional information be reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

Healthcare professional reported patient experienced "chocolate milk drainage and when taken back to the or (they) had 475 cc of puss and the strattice had melted away.Cultures showed a staph infection".

Manufacturer Narrative

Conclusion: the internal investigation into lot sp100620 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no related complaints reported against the lot and no processing deviations or nonconformances.The lot was aseptically processed, terminally sterilized within the process parameters and met all qc release criteria.As of date, of the 405 devices released to finished goods for lot sp100620, 396 have been distributed including 29 reported as implanted.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.

Event Description

This is a follow up #1 to report additional event information.Remnant was removed.As reported in the initial: healthcare professional reported patient experienced "chocolate milk drainage and when taken back to the or [they] had 475 cc of puss and the strattice had melted away.Cultures showed a staph infection".

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8155349
• MDR Text Key: 130060199
• Report Number: 1000306051-2018-00149
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CON3006
• Device Lot Number: SP100620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Required Intervention