MAUDE Adverse Event Report: LIFECELL 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	Seroma (2069); 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 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
Limited information was reported through a legal event that a patient was implanted with strattice perforated on (b)(6) 2022.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 legal event is being reported as serious injury due to the reported recurrence with surgical intervention.A review of the device history record for strattice lot sp200223 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.No strattice devices were returned for evaluation.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 18/dec/2023, 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¿ repair and was implanted with strattice device lot sp2000223-043 on (b)(6) 2022.The patient underwent an "open abdominal wall exploration, excision of indwelling biological mesh deep/incorporated from fascia & suture foreign body; excision of cyst capsule; primary repair of bilateral anterior rectus fascial defects measuring approx.6 cm wide x 15 cm long right & left¿ on (b)(6)2022.The patient also underwent ¿revision surgery¿ 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, scarring and disfigurement, and economic and non-economic losses¿.Patient ¿has been hospitalized, undergone surgical procedures and physical therapy.¿ patient ¿suffers from abdominal pain.¿ patient ¿has lifting restrictions and had to adjust [their] physical activities.¿ patient "has difficulty walking long distances, standing for extended periods of time, and driving for long periods of time in a car.¿ patient ¿no longer gardens or goes boating due to [their] continued pain.[patient] is dependent on others to help with daily tasks [they] has difficulty completing [themselves].[patient] wears an uncomfortable stomach binder.[patient] has difficulty participating in family outings and activities due to pain.[their] stomach is scarred and causes [them] embarrassment.[patient] is fearful [they] will suffer another hernia in the future.These injuries contribute to [patient¿s] anxiety and depression.¿.The form lists the conditions that were treated were ¿incisional abdominal wall hernia repair ¿ open -myofascial flap with biologic mesh (strattice)¿ with approximate dates of treatment as (b)(6) 2022.The patient also received treatment for ¿right side abdominal pain next to incisional hernia repair (postop pain); ct scan: small seroma¿ on (b)(6) 2022.The patient received treatment for ¿chronic seroma associated with hernioplasty mesh & intractable abdominal pain with bilateral myofascial advancement flaps with wound vac placement (excision of mesh in its entirety)¿ between (b)(6) 2022 and (b)(6) 2022.The patient also received treatment for ¿abdominal pain; anxiety; depression; stress¿ from approximately (b)(6) 2022 to present.The patient received treatment for ¿abdominal pain; fatigue¿ on (b)(6) 2023.The patient received ¿physical therapy; activating abdominal muscles; exercises to strengthen abdominal muscles; manual therapy techniques¿ on ¿various dates.¿ patient received treatment for ¿constipation; generalized abdominal pain¿ on (b)(6) 2023.The patient received treatment for ¿post-2022 revision abdominal pain; visible bulges in abdominal area; referral to pt¿ in the year 2023.The patient also received treatment for ¿mesh excision and revision surgeries; mesh complications; chronic abdominal pain; follow-up¿ from (b)(6) 2022 to present.The patient received treatment of ¿revision surgery¿ on (b)(6) 2023.The ppf form also indicates the patient was implanted with a non-abbvie device, "surgimesh, lot #tintrac10¿ on (b)(6) 2015 and on (b)(6) 2022 was revised due to ¿incisional abdominal wall hernia repair-open-myofascial flap with biological mesh.¿ in addition, on (b)(6) 2022, the patient had ¿open abdominal wall exploration, excision of indwelling biologic mesh deep/incorporated from fascia and suture foreign body, excision of cyst capsule, primary repair of bilateral anterior rectus fascial defects measuring approximately 6 cm wide x 15 cm long right and left¿ and on (b)(6) 2023 ¿revision surgery.¿.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice perforated on (b)(6) 2022.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): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 17733140
• Report Number: 1000306051-2023-00216
• Device Sequence Number: 20468768
• Product Code: FTM
• UDI-Device Identifier: 00818410012298
• UDI-Public: 00818410012298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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 Expiration Date: 04/30/2022
• Device Catalogue Number: 1620002P
• Device Lot Number: SP200223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 47 YR
• Patient Sex: Female