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

Model Number	MSPL1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported seroma formation 6 to 8 weeks 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 fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
Event or Problem Description
On 4/16/2018 acell received notification from physician regarding a patient who experienced post operative fluid drainage after treatment with an acell device.Patient had epigastric hernia 12 cm in length which was repaired with an acell surgical graft on (b)(6) 2018.Patient has had fluid accumulating in her subcutaneous space which has required fluid drainage evacuated 6 to 8 weeks post operative.

• Brand Name: GENTRIX SURGICAL MATRIX PLUS
• Common Device Name: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 7537892
• Report Number: 3005920706-2018-00003
• Device Sequence Number: 16598802
• Product Code: FTM
• UDI-Device Identifier: 00386190001240
• UDI-Public: (01)00386190001240(17)191130(10)010768
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K162554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: 11/30/2019
• Device Model Number: MSPL1015
• Device Catalogue Number: MSPL1015
• Device Lot Number: 010768
• 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: 04/16/2018
• Initial Report FDA Received Date: 05/23/2018
• 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