MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problem Bacterial Infection (1735)

Event Date 09/14/2019

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported infection with graft explant.Due to the legal process, if additional information is made available during legal proceedings the appropriate department will forward the information to product surveillance for further evaluation.The lot associated with this event was invalid and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, a relationship to the strattice was not determined.No further actions are required, a nonconformance was not confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

It was reported through legal, that a (b)(6) year old male at the time underwent a recurrent incarcerated ventral hernia repair at methodist health system in (b)(6).The patient was implanted with strattice.The patient returned to the hospital 11 years later on (b)(6) 2019 and was diagnosed with infected mesh and on the same day, the mesh was explanted at (b)(6).Lot s10486-048 is not coming up as a valid lot; therefore, the lot has been updated to unknown.

Event Description

This is follow up#1 to report that on september 14th, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is s10468-046.No other information was reported.However, this is not a valid lot number and the lot associated with this event remains unknown.As reported in the initial: it was reported through legal, that a 47 year old male at the time underwent a recurrent incarcerated ventral hernia repair at (b)(6).The patient was implanted with strattice.The patient returned to the hospital 11 years later on (b)(6) 2019 and was diagnosed with infected mesh and on the same day, the mesh was explanted at guadeloupe regional medical center, seguin, texas.Lot s10486-048 is not coming up as a valid lot; therefore, the lot has been updated to unknown.

Manufacturer Narrative

Although a lot number was reported, the lot number is not valid and therefore an internal investigation cannot be performed.Based on the limited information, a relationship to the strattice was not determined.If additional information is received, a supplemental report will be submitted.As reported in the initial: this legal event is being reported as serious injury due to the reported infection with graft explant.Due to the legal process, if additional information is made available during legal proceedings the appropriate department will forward the information to product surveillance for further evaluation.The lot associated with this event was invalid and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, a relationship to the strattice was not determined.No further actions are required, a nonconformance was not confirmed.If additional information is received, a supplemental report will be submitted.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12568993
• MDR Text Key: 274523986
• Report Number: 1000306051-2021-03061
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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: UNK STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• 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; NO INFORMATION
• Patient Outcome(s): Required Intervention
• Patient Sex: Male