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

Model Number	PSMT2020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported wound dehiscence and seroma formation after initial placement of the acell device.The device 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.
Event or Problem Description
On 11/8/1209, acell, inc.Was notified by a surgeon that a patient experienced a seroma four (4) months post operative ventral hernia repair with an acell device placed as an onlay on (b)(6) 2019.The patient experienced a wound dehiscience at repair site on (b)(6) 2019.The wound was drained and debrided on (b)(6) 2019, the wound was cultured with no infection present.

• 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: 9418117
• Report Number: 3005920706-2019-00021
• Device Sequence Number: 16277122
• Product Code: FTM
• UDI-Device Identifier: 00386190001547
• UDI-Public: (01)00386190001547(17)200630(10)012912
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

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: 06/30/2020
• Device Model Number: PSMT2020
• Device Catalogue Number: PSMT2020
• Device Lot Number: 012912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• 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
• Patient Age: 71 YR