MAUDE Adverse Event Report: STRATTICE PERFORATED 20 X 25; MESH, SURGICAL

Catalog Number 2025002P

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

Patient Problem Hernia (2240)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Internal investigation into strattice lot sp200137 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 complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 9/24/21, of the (b)(4) devices released to finished goods, (b)(4) have been distributed with (b)(4) devices reported as implanted.

Event Description

It was reported through legal, that a (b)(6) year old male patient underwent hernia repair surgery on (b)(6) 2019 at (b)(6) hospital in (b)(6).The patient was implanted with strattice lot sp200137-016.After surgery, the patient returned to the hospital in early 2020 and was diagnosed with fluid in his abdomen and recurrent hernia.It has been suggested that the patient have mesh removal surgery.

• Brand Name: STRATTICE PERFORATED 20 X 25
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12569006
• MDR Text Key: 274567246
• Report Number: 1000306051-2021-03062
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410012335
• UDI-Public: 00818410012335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2025002P
• Device Lot Number: SP200137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• 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
• Patient Outcome(s): Required Intervention