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

Model Number PSMX1015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Seroma (2069)

Event Date 12/07/2020

Event Type  Injury  

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 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
• Type of Device: GENTRIX SURGICAL MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 11121311
• MDR Text Key: 228612642
• Report Number: 3005920706-2020-00014
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001875
• UDI-Public: (01)00386190001875(17)220731(10)023048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other