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

Model Number	PSMX1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Seroma (2069)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported seroma and fever after initial placement of the acell device.The device was not explanted and is performing as expected.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 (b)(6) 2020, acell, inc.Was notified that a patient experienced a fever and seroma post implantation of two gentrix devices.The gentrix devices were implanted on (b)(6) 2020 for a c-section.The devices were placed in the uterus incision within the muscle and fascia.The devices were cut down to a smaller size to accommodate the smaller incision and then tacked in place in 4 corners.On (b)(6) 2020, the patient stated having a fever and went to the er.The patient was admitted, and was showing fluid in two spaces from the cat scan.The patient was placed on antibiotics during this visit and was discharged a day later.The patient made an additional visit to the er on (b)(6) 2020 for a fever and abdominal pain.The patient was given antibiotics during this visit and discharged a day later.There was no surgical intervention to resolve the seroma for both visits to the er on (b)(6) 2020 and (b)(6) 2020.The gentrix devices remains in place and are functioning as intended.

• Brand Name: GENTRIX SURGICAL MATRIX
• Common Device Name: GENTRIX SURGICAL MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia MD 21046
• MDR Report Key: 11121311
• Report Number: 3005920706-2020-00014
• Device Sequence Number: 846334
• Product Code: FTM
• UDI-Device Identifier: 00386190001875
• UDI-Public: (01)00386190001875(17)220731(10)023048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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: 07/31/2022
• Device Model Number: PSMX1015
• Device Catalogue Number: PSMX1015
• Device Lot Number: 023048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• 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