MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM; SYSTEM, SUCTION, LIPOPLASTY

Catalog Number	2540002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a legal event that a 70 year old female patient had hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice 2540002 firm mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016, reporting abdominal pain and was diagnosed with a large lower abdominal hernia.On or about (b)(6) 2016, the underwent a recurrent incisional hernia repair with mesh and left muscle transfer flap.On or about (b)(6) 2019, the presented back to the hospital and was diagnosed with a recurrent ventral hernia.She underwent a repair of a recurrent incarcerated incisional hernia with mesh and lysis of adhesions.This record is associated with the device implanted on (b)(6) 2014.
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
Event or Problem Description
This is follow up#1 to report on 17/oct/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is log314386.No other information was reported.Although a lot number was reported, the lot number is not valid, therefore, the lot associated with this event remains unknown.As reported in the initial: it was reported through a legal event that a 70 year old female patient had hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice 2540002 firm mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2016, reporting abdominal pain and was diagnosed with a large lower abdominal hernia.On or about (b)(6) 2016, the underwent a recurrent incisional hernia repair with mesh and left muscle transfer flap.On or about (b)(6) 2019, the presented back to the hospital and was diagnosed with a recurrent ventral hernia.She underwent a repair of a recurrent incarcerated incisional hernia with mesh and lysis of adhesions.This record is associated with the device implanted on (b)(6) 2014.
Additional Manufacturer Narrative
The lot number associated with this event was found through discovery and is log314386.However, the lot number provided is an invalid lot number, therefore, the lot associated with this event remains unknown and the investigation conclusion remains unchanged.Based on the limited information reported, a relationship between the event and strattice cannot be determined.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 15041895
• Report Number: 1000306051-2022-00119
• Device Sequence Number: 5450951
• Product Code: FTM
• UDI-Device Identifier: 00818410010416
• UDI-Public: 00818410010416
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2540002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO INFORMATION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female