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 Hernia (2240)

Event Date 12/06/2011

Event Type  Injury  

Event Description

Limited information was reported through a legal event that a (b)(6) female underwent hernia repair on or about (b)(6) 2011.During the patient¿s surgery, the surgeon implanted him with strattice, no lot number was reported.After surgery, the patient returned to the hospital on or about (b)(6) 2011 and was diagnosed with hernia reoccurrence and adhesions.During the (b)(6) 2011, procedure strattice was explanted and a new strattice graft was implanted, no lot number was reported.Lysis of adhesions and bilateral component separation was performed.On (b)(6) 2012 a second revision surgery was performed and strattice was explanted.Fat necrosis was noted and excised over the mesh and seroma was noted.In 2019 the patient underwent additional surgeries for hernia repair.No other information was reported.

Manufacturer Narrative

The lot associated with this event was not reported 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 reported, a relationship between the event and strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation.To date, no additional information has been received.No further actions are required, a nonconformance was not confirmed.

Event Description

This is follow up#1 to report that on september 9, 2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is s10825-087 and on september 14 pmqa received a notification from legal that lot s10825-087 was implanted on (b)(6) 2011.Although a lot number was reported, the lot number is not valid, and the lot associated with this event remains unknown.No other information was provided.As reported in the initial: limited information was reported through a legal event that a 65-year-old female underwent hernia repair on or about (b)(6) 2011.During the patient¿s surgery, the surgeon implanted him with strattice, no lot number was reported.After surgery, the patient returned to the hospital on or about (b)(6) 2011 and was diagnosed with hernia reoccurrence and adhesions.During the (b)(6) 2011, procedure strattice was explanted and a new strattice graft was implanted, no lot number was reported.Lysis of adhesions and bilateral component separation was performed.On (b)(6) 2012 a second revision surgery was performed and strattice was explanted.Fat necrosis was noted and excised over the mesh and seroma was noted.In 2019 the patient underwent additional surgeries for hernia repair.No other information was reported.

Manufacturer Narrative

Additional information was received from legal that indicated the lot associated with this event was s10825-087 however, the lot number is not valid and therefore, no internal investigation can be preformed.The lot associated with this event remains unknown.The conclusion remains the same.Based on the limited information reported, a relationship between the event and strattice cannot 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: 14437154
• MDR Text Key: 292041602
• Report Number: 1000306051-2022-00097
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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
• Date Manufacturer Received: 09/08/2022
• 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; NO INFORMATION REPORTED
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female