MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hernia (2240); Insufficient Information (4580)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

No lot information provided.If additional information is received a follow up will be submitted.

Event Description

Patient representative reported (b)(6) male patient had a hernia repair on (b)(6) 2017 with strattice.On (b)(6) 2019, he was diagnosed with an infected mesh and required explant two years post operation.

Event Description

This is follow up #1 to report that additional information was received from legal on june 7, 2022 that the valid lot number associated with this event is sp100559.As reported in the initial: patient representative reported 50yo male patient had a hernia repair on (b)(7) 2017 with strattice.On (b)(6) 2019, he was diagnosed with an infected mesh and required explant two years post op.

Manufacturer Narrative

Internal investigation into strattice lot sp100559 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 related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 06/21/2022, of the (b)(4) devices released to finished goods for lot sp100559, 189 have been distributed with 96 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: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12124711
• MDR Text Key: 264859681
• Report Number: 1000306051-2021-03028
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male