MAUDE Adverse Event Report: BRANCHBURG STRATTICE PERFORATED 16 X 20; MESH, SURGICAL

Catalog Number	1620002P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2019.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.
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.Additional and/or corrected data: a2, b3, b5, b6, b7, d4, d6b, h6.
Event or Problem Description
This is follow up#1 to report on 27/aug/2025, 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 incisional hernia surgery and was implanted with a strattice device lot #sp200007, ref.# (b)(4) on (b)(6) 2019.Capturing catalog number as 1620002p.On (b)(6) 2020, patient underwent primary repair of small incisional hernia.On (b)(6) 2022, exploratory laparotomy with lysis of adhesions and removal of foreign body performed.Patient also underwent evacuation of abdominal wall seroma and repair of ventral hernia.On (b)(6) 2023, another exploratory laparotomy, lysis of adhesions, with a removal of infected mesh, reduction and repair of recurrent ventral hernia.Wound vac placement into abdominal wall tap block.On (b)(6) 2023, patient underwent open complex abdominal wall reconstruction with myofascial release of the rectus sheath x2, resection of redundant skin and subcutaneous tissue.Patient was implanted with a non-abbvie device, bard mesh soft, lot #huhs0593.The form lists the condition that was treated: (b)(6) 2019 - explantation of hernia mesh, debridement and drainage of intra-abdominal abscess, partial small bowel resection with anastomosis, placement of retro rectus biologic mesh for hernia repair (stratus); wound vac.(b)(6) 2019 - post-op abdominal wall seroma; placement of pigtail catheter, seroma fluid drained (in-office procedure).(b)(6) 2019 - abdominal pain and swelling; placement of percutaneous drain and seroma/abscess fluid drained (bedside procedure).(b)(6) 2020 - primary repair of small incisional hernia.(b)(6) 2022 - worsening abdominal pain, n/v, small bowel obstruction, abdominal wall hernia, chronic seroma.(b)(6) 2022 - exploratory laparotomy, lysis of adhesions, removal of foreign body, evacuation of abdominal wall seroma, repair of ventral hernia.2023 - recurrent midline abdominal seroma: pigtail catheter placements, multiple aspirations of seroma.(b)(6) 2023 - abdominal wall cellulitis, seroma, infection, and abscess; exploratory laparotomy, lysis of adhesions, removal of infected mesh.2023-2024 - home healthcare; wound management; wound vac management mesh, reduction and repair of recurrent ventral hernia, wound vac placement, abdominal wall tap block.(b)(6) 2023 - abdominal pain, n/v; small bowel obstruction, incarcerated hernia (conservative treatment).(b)(6) 2023 - abdominal pain, n/v; small bowel obstruction; ventral hernia with obstruction.(b)(6) 2023 - recurrent small bowel obstruction (conservative treatment).(b)(6) 2023 - abdominal pain, n/v; open complex abdominal wall reconstruction with myofascial release of the rectus sheath x2, resection of redundant skin and subcutaneous tissue (bard mesh implanted); debridement ct abdomen/pelvis: moderate to high-grade small bowel obstruction.(b)(6) 2023 - partial dehiscence of incision site.Nov (b)(6) 2024 - home healthcare; wound management.(b)(6) 2023 - skin red and indurated in lower midline abdominal wound, abdominal wall cellulitis.(b)(6) 2023 - wound infection, subcutaneous wound seroma, superficial wound dehiscence, placement of percutaneous pigtail catheter (aspiration/drainage) (local used).2023, 2024 - wound management.From 2019 to present - hernia symptoms, hernia surgeries and repair, bowel obstructions, abdominal wall reconstruction, follow-ups, wound management.Various dates 2023-2024 - fluoroscopic drain injections with sclerotherapy, removal of drainage catheters, percutaneous catheter placements (for abdominal abscesses/seroma drainages/aspirations).2019-2023 - abdominal wall seroma/abscess; ct and us scans, seroma/abscess drainages.2018-present - hernia symptoms, follow-ups, wound management, primary care, anxiety, depression.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2019.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.

• Brand Name: STRATTICE PERFORATED 16 X 20
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): BRANCHBURG; 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: 20152867
• Report Number: 1000306051-2024-00237
• Device Sequence Number: 4235730
• Product Code: FTM
• UDI-Device Identifier: 00818410012298
• UDI-Public: (01)00818410012298
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 1620002P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Female