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

Model Number PSMT3040

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

Patient Problem Seroma (2069)

Event Date 10/21/2020

Event Type  Injury  

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 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 10/21/2020, acell, inc.Was notified that a gentrix device was partially explanted due a seroma.The gentrix device was implanted on (b)(6) 2020 due to a recurrent incisional hernia; a prior mesh sepramesh was removed at this time.The gentrix was placed in the recto-rectus spaced with a drain.Patient had a pre-existing infection where the gentrix was placed.On (b)(6) 2020 the patient was shown to have fluid building up above the device, surgeon reoperated and debrided area around gentrix device.The majority of the acell device (>90%) remains in the retrorectus space and is functioning as intended.

• Brand Name: GENTRIX SURGICAL MATRIX THICK
• Type of Device: GENTRIX SURGICAL MATRIX THICK
• 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: 10836236
• MDR Text Key: 216125414
• Report Number: 3005920706-2020-00011
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001585
• UDI-Public: (01)00386190001585(17)210430(10)016368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

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
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: PSMT3040
• Device Catalogue Number: PSMT3040
• Device Lot Number: 016368
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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
• Treatment: SEPRAMESH
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR