MAUDE Adverse Event Report: STRATTICE LAPAROSCOPIC 16CM X 20CM; MESH, SURGICAL

Catalog Number	1620005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Foreign Body Reaction (1868)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 48 year old female patient underwent hernia repair surgery on or about (b)(6) 2019.During the hernia repair surgery, the surgeon implanted a strattice mesh; catalog 1520005, lot no.Sp100632-139.After surgery, the patient returned to the hospital on or about (b)(6) 2019 and was diagnosed with an extreme fibrotic reaction to strattice and abdominal wall infection and underwent a mesh removal operation.
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100632 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other related complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of (b)(6) 2022, of the (b)(4) devices released to finished goods for lot sp100632, 185 have been distributed with 100 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.

• Brand Name: STRATTICE LAPAROSCOPIC 16CM X 20CM
• Common Device Name: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14653660
• Report Number: 1000306051-2022-00106
• Device Sequence Number: 11953240
• Product Code: FTM
• UDI-Device Identifier: 00818410012885
• UDI-Public: 00818410012885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1620005
• Device Lot Number: SP100632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female