MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX THICK

Model Number	PSMT3040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported usual drainage and subsequent bacterial infection after initial placement of the acell device.The device was explanted, however, it is not available for evaluation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.There were no reports of device failure at the time of initial surgery.
Event or Problem Description
On (b)(6) 2018, acell, inc.Became aware that a patient had unusual drainage after an open retrorectus repair with transversus abdominis (tar) release with an acell device on (b)(6) 2018.The patient had normal drainage post operatively for 3 days.A ct scan was done on (b)(6) 2018, which was normal and the surgical drains were removed.There was a sudden appearance of dark, odorous, stool like drainage on (b)(6) 2018.Upon exploration of the drainage site, the device, muscle and periosteum were found to be bathed in a puss like material.The drainage was cultured and was positive for enterococcus avium.The patient has no other history of this bacterium.The device was explanted on (b)(6) 2018.The patient is doing fine and undergoing the following treatment every other day: abdominal lavage, i&d, vicryl covering, and npwt (abthera).All acell devices are terminally sterilized prior to distribution.

• Brand Name: GENTRIX SURGICAL MATRIX THICK
• Common Device Name: GENTRIX SURGICAL MATRIX THICK
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 7953442
• Report Number: 3005920706-2018-00016
• Device Sequence Number: 16215630
• Product Code: FTM
• UDI-Device Identifier: 00386190001585
• UDI-Public: (01)00386190001585(17)200831(10)013345
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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: 08/31/2020
• Device Model Number: PSMT3040
• Device Catalogue Number: PSMT3040
• Device Lot Number: 013345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 41 YR