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

Model Number	PSMT1620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported seroma formation after initial placement of the acell device.The device was not explanted and 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 regulation.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 experienced seromas post operative after a ventral hernia repair procedure with an acell device on (b)(6) 2017.The surgery was for a recurrent hernia.Patient had 3 prior surgeries in 2008, 2011 and 2014 for hernia repair with other surgeons.There was no other information provided regarding these prior surguries.After surgery on (b)(6) 2017, patient indicated having several drainage episodes post operative.Surgeon confirmed the patient experienced two seromas while still under his care and after the second drainage episode the fluid was cultured with no growth observed.The surgeon described the fluid as clear and sterile.Surgeon has not seen patient since (b)(6) 2017.Patient confirmed discontinuing care from surgeon who performed hernia repair on (b)(6) 2017 and is continuing care with another undisclosed physican.Patient has health issues that include hypertension, high cholesterol, bronchial asthma and a heart murmur.Patient is also a smoker, with a 12 cigarette a day habit.

• 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: 7563553
• Report Number: 3005920706-2018-00006
• Device Sequence Number: 10807715
• Product Code: FTM
• UDI-Device Identifier: 00386190001530
• UDI-Public: (01)00386190001530(17)190131(10)007818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: PSMT1620
• Device Catalogue Number: PSMT1620
• Device Lot Number: 007818
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/01/2018
• 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: Required Intervention
• Patient Age: 51 YR