MAUDE Adverse Event Report: LIFECELL 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); Fluid Discharge (2686)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence, adhesions, and drainage 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
On 01/feb/2024, legal received limited information that a patient was implanted with strattice on (b)(6) 2019.On 09/apr/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 an ¿incisional hernia¿ surgery and was implanted with strattice device on (b)(6) 2019.The patient underwent a ¿repair of recurrent incisional hernia using 25 x 20 cm phasix mesh, extensive lysis of adhesion; application of prevena vac¿ on (b)(6) 2022.The patient also underwent a ¿repair of recurrent incisional hernia using 30 x 25 cm phasix mesh, extensive lysis of adhesion, application of prevena vac, creation of bilateral subcutaneous flaps¿ on (b)(6) 2023.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain and suffering, physical injury, loss of enjoyment of life, and economic and non-economic losses as a result of [their] strattice implant.¿ patient ¿suffers from abdominal pain and discomfort.¿ patient "has been hospitalized and undergone multiple surgical procedures.¿ patient ¿is dependent on others to help with daily tasks [they have] difficulty completing [themselves].¿ patient ¿has lifting restrictions and had to adjust [their] physical activities.¿ patient ¿has difficulty playing basketball, bowling, and lifting/playing with [their] dog.¿ patient " has trouble sleeping.¿ patient ¿wore an uncomfortable stomach binder.¿ patient ¿has difficulty participating in family outings and activities due to pain and discomfort, such as lifting his grandchildren and participating in physical activities with them.¿ patient¿s ¿stomach is scarred and disfigured which causes [them] embarrassment.¿ patient " is fearful he will suffer another hernia in the future.¿ the form lists the conditions that were treated were ¿exploratory laparotomy, lysis of adhesions, incisional hernia repair with bilateral anterior component separation and onlay strattice 20 x 35 cm mesh, prevena vac¿ with approximate dates of treatment between (b)(6) 2019 and (b)(6) 2019.The patient was also treated for ¿suprapubic abdominal pain, jp drain in rlq abdomen with serosanguineous white drainage¿ between (b)(6) 2019 and (b)(6) 2019.Patient was treated for ¿abdominal pain with swelling around right upper quadrant region¿ and ¿ct abdomen/pelvis - residual fluids in anterior abdominal wall, considerable interval increases in anterior abdominal wall¿ between (b)(6) 2019 and (b)(6) 2019.Patient was treated for ¿recurrent abdominal induration, redness, pain¿ on or about (b)(6) 2019.Patient underwent ¿repair of recurrent incisional hernia using 25 x 20 cm phasix mesh, extensive lysis of adhesion, application of prevena vac¿ between (b)(6) 2022 and (b)(6) 2022.Patient received treatment for ¿incisional pain/hernia, abdominal pain¿ on or about (b)(6) 2023.Patient had ¿repair of recurrent incisional hernia using 30 x 25 cm phasix mesh, extensive lysis of adhesion, application of prevena vac, creation of bilateral subcutaneous flaps¿ between (b)(6) 2023 and (b)(6) 2023.The ppf form also indicates the patient was implanted with a non-abbvie device, ¿phasix mesh¿ on (b)(6) 2022.The form indicates that this device was revised on (b)(6) 2023 due to ¿reconstruction of abdominal wall with component separation technique implantation of mesh.¿ the patient was implanted with another non-abbvie device, ¿phasix mesh¿ on (b)(6) 2023.The form indicates that this device has not been revised or removed.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• 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 ; 9089471470
• MDR Report Key: 19101521
• Report Number: 1000306051-2024-00089
• Device Sequence Number: 12704249
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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: 02/01/2024
• Initial Report FDA Received Date: 04/12/2024
• 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: 58 YR
• Patient Sex: Male