MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM; MESH, SURGICAL

Catalog Number	3030002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This legal event is being reported as serious injury due to the reported infection with surgical intervention.A review of the device history record for strattice lot sp100458 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.A relationship between the strattice and this event could not be conclusively 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) 2013 and (b)(6) 2017.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.This record is associated with the device implanted on (b)(6) 2017.Additional information was received through the ppf form that states: the underwent a surgery for a ventral hernia and the patient was implanted with lot #sp100458-095.From post (b)(6) 2017 the patient was treated for "wound care including wound vac; recovery from extensive abdominal surgery/open ventral hernia repair; pt/ot".On (b)(6) 2017, the condition treated is listed as "increased pain diffusely; abdominal pain; drains fell out and serous drainage from right lower drain; nausea and vomiting; fever; abscess; given iv antibiotics" on (b)(6) 2017, the patient underwent a "ct guidance for needle placement; abdominal wall abscess drainage with interpretation".The patient claims the following resulted from the implantation of the strattice mesh: the patient has experienced pain and suffering, physical injury, loss of enjoyment of life, scarring and disfigurement, and economic and non-economic losses as a result of his strattice implant.He has been hospitalized and undergone several procedures.The patient suffered from wound infections and abscesses.He was bedridden for almost a month and a half.He received iv antibiotics.He was placed on a wound vac for several months that he had to wear whileshowing houses as a realtor, which caused him embarrassment.A wound care nurse came approximately 3 times a week to change his dressings.He had physical and occupational therapy due to extreme weakness.The patient is dependent on others to help with daily tasks he has difficulty completing by himself.He has difficulty participating in the care for his special needs son.He has been unable to participate in family outings and activities due to his pain and weakness.The patient has lifting restrictions causing him to adjust his physical activities.He is unable to play tennis or exercise which caused him to gain weight.He has difficulty sleeping.He is fearful he will suffer from another hernia in the future.These injuries contribute to the patient's ongoing depression and anxiety.No other information was provided.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 30 X 30CM, FIRM
• 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: 17878966
• Report Number: 1000306051-2023-00244
• Device Sequence Number: 15305928
• Product Code: FTM
• UDI-Device Identifier: 00818410011796
• UDI-Public: 00818410011796
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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: 09/30/2018
• Device Catalogue Number: 3030002
• Device Lot Number: SP100458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2016
• 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: 54 YR
• Patient Sex: Male