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	Unspecified Infection (1930); Hernia (2240)
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) 2014 and (b)(6) 2015.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 (b)(6) 2015.This is the same event and the same patient reported under mdr # 1000306051-2023-00182 (abbvie complaint # (b)(4)).
Additional Manufacturer Narrative
Additional and/or corrected data: a.2, a.3, b.5, b.6, d.1, d.4, d.6b, h.4, h.6.A review of the device history record for strattice lot sp100289 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
On 02/oct/2023, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, patient had additional strattice device implanted for ¿ventral hernia.¿ on (b)(6) 2016 patient underwent ¿excision and irrigation and debridement (i&d)-wounds and removal of retained mesh.¿ as per the ppf form, the patient claims the implantation and failure of the mesh caused ¿no longer has any abdominal muscle,¿ ¿extremely self-conscious,¿ ¿constant pain,¿ ¿multiple abdominal hernia defects with panniculitis and an abdominal wall abscess.¿ the form lists the conditions that were treated were ¿recurrent incisional hernia (abdominal hernia defect)¿ and ¿abdominal wall abscess with approximate dates of treatment as (b)(6) 2015 and (b)(6) 2016.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, 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: 17653399
• Report Number: 1000306051-2023-00183
• Device Sequence Number: 7269292
• Product Code: FTM
• UDI-Device Identifier: 00818410010416
• UDI-Public: 00818410010416
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 07/31/2017
• Device Catalogue Number: 2540002
• Device Lot Number: SP100289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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: Female