MAUDE Adverse Event Report: LIFECELL 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET; MESH, SURGICAL

Catalog Number	0610008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Type of Reportable Event	Serious Injury
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 a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, 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
Limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2020.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
Event or Problem Description
On (b)(6) 2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent a ¿left flank hernia repair¿ and was implanted with strattice device lot unknown on (b)(6) 2020.The patient underwent a " lysis of adhesions, abdominal repair, and open ventral repair using component separation technique¿ on (b)(6) 2022.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, adhesions,and intervention surgery¿.The form lists the conditions that were treated were ¿pain, recurrence, adhesions, and intervention surgery¿ with approximate dates of treatment as (b)(6) 2022.The ppf form also indicates the patient was implanted with a non-abbvie device, "ethicon prolene phm ¿ lot #unknown¿ during the (b)(6) 2020 procedure.The patient was implanted with another non-abbvie device, "bard soft mesh;¿ during the (b)(6) 2022 procedure.Neither of these non-abbvie devices have been removed or revised.
Additional Manufacturer Narrative
Additional and/or corrected data: a2, b5, d1, d4, h6.

• Brand Name: 6CM X 10CM STRATTICE FIRM STOMA REINFORCED SHEET
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 8479366324
• MDR Report Key: 18311574
• Report Number: 1000306051-2023-10013
• Device Sequence Number: 17798707
• Product Code: FTM
• UDI-Device Identifier: 00818410010041
• UDI-Public: 00818410010041
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 0610008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male