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

Catalog Number 1620005

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

Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868)

Event Date 06/06/2019

Event Type  Injury  

Event 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.

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
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 14653660
• MDR Text Key: 294858927
• Report Number: 1000306051-2022-00106
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410012885
• UDI-Public: 00818410012885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 1620005
• Device Lot Number: SP100632
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female