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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX THICK Back to Search Results
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.
 
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Brand NameGENTRIX SURGICAL MATRIX THICK
Type of DeviceGENTRIX 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 Key10836236
MDR Text Key216125414
Report Number3005920706-2020-00011
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Model NumberPSMT3040
Device Catalogue NumberPSMT3040
Device Lot Number016368
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/13/2020 Patient Sequence Number: 1
Treatment
SEPRAMESH
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