MAUDE Adverse Event Report: BRANCHBURG STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM; MESH, SURGICAL

Catalog Number	2540002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	05/03/2016
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) 2016.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.
Event or Problem Description
This is follow up#1 to report on 21/aug/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 incarcerated incisional hernia surgery and was implanted with a strattice device lot unknown and catalog number 2540002 on (b)(6) 2016.On (b)(6) 2017, patient underwent an exploratory laparoscopy, resection of umbilical incisional hernia with mesh from periumbilical region.On (b)(6) 2021, patient underwent robotic repair of ventral hernia with mesh, right-sided transverses abdominis release.As per the ppf form, the patient claims: pain and suffering, physical injury, loss of enjoyment of life, economic and non-economic losses as a result of her strattice implant.Patient suffers from abdominal tenderness.Patient is dependent on others to help with daily tasks, has difficulty completing them.Patient had lifting restrictions and had to adjust physical activities.Patient has difficulty driving for long periods of time and walking long distances.They have difficulty sleeping, wears an uncomfortable compression binder and stomach is scarred and disfigured causing embarrassment.These injuries contribute to their depression.The form lists the condition that was treated was: hernia symptoms/abdominal pain between 2016 - 2017.Worsening of umbilical hernia-incarcerated with omentum, incisional hernia repair with strattice mesh, umbiloplasty between (b)(6) 2016.Pain & discomfort in periumbilical area, ct migration of mesh laterally, no hernia recurrence on (b)(6) 2016.Post abdominal hernia repair pain, hernia repair & follow-up from 2016-2017.General health maintenance, depression, hernia symptoms on 2016 to present.Abdominal pain secondary to prior ventral hernia repair, exploratory laparoscopy, resection of umbilical incisional hernia with mesh from periumbilical region, extensive lysis of adhesions on (b)(6) 2017.Pain at umbilicus where mesh was removed, ct - no evidence of recurrent hernia on (b)(6) 2018.Pain, ct of (b)(6) 2020 - right-sided hernia containing loop of large bowel, without evidence of obstruction or incarceration, scarring at umbilicus, no surgical intervention on (b)(6) 2020.Further evaluation of ventral incisional hernia, hernia in right upper quadrant at semilunaris (incisional hernia from prior laparoscopic right oophorectomy), bulge in right abdomen - only able to partially reduce, surgery scheduled on (b)(6) 2020.Robotic repair of ventral hernia with mesh, right-sided transverses abdominis release between (b)(6) 2021.Depression approximately 2022 to present.The ppf form also indicates that the patient was implanted with a non-abbvie device, ¿bard marlex soft b041010, log 454982¿ on (b)(6) 2021.The form indicates that the device has not been removed/revised.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2016.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 RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 19751135
• Report Number: 1000306051-2024-00190
• Device Sequence Number: 8850485
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 2540002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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: 45 YR
• Patient Sex: Female