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 Code	Hernia (2240)
Date of Event	06/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal investigation into strattice lot sp100288 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 confirmed 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 4/27/2022, of the 221 devices released to finished goods for lot sp100288, 188 have been distributed with 141 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 or Problem Description
It was reported through a legal event that a (b)(6) male patient underwent hernia repair surgery on or about (b)(6) 2015.During the hernia repair surgery, the surgeon implanted a strattice mesh lot sp100151-096.After surgery, the patient returned to the hospital on or about (b)(6) 2016 and was diagnosed with a recurrent hernia.On or about (b)(6) 2016 the patient underwent a mesh revision operation.As part of the revision surgery, the surgeon implanted another strattice mesh, lot no.Sp100288-057.Following the revision surgery, the patient again returned to the hospital on (b)(6), 2016, where the patient was diagnoses with a recurrent incarcerated ventral hernia.On (b)(6) 2016, the surgeon implanted a third strattice mesh, lot no.Sp100503-132.This record is associated with the second device implanted on (b)(6), 2016, lot sp100288-057.As per the reported information, there is no complaint against the third device lot sp100503-132.

• 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: 14305436
• Report Number: 1000306051-2022-00088
• Device Sequence Number: 4795117
• Product Code: FTM
• UDI-Device Identifier: 00818410012885
• UDI-Public: 00818410012885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K130817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/05/2022

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: SP100288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/06/2022
• 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 Sex: Male