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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX PLUS Back to Search Results
Model Number MSPL1015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Obstruction/Occlusion (2422)
Event Date 01/25/2019
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported fascial dehiscence with bowel obstruction requiring emergent surgery and hospitalization. Upon exploration for management of the event, it was the operating surgeon's opinion that the fascial dehiscence was not the result of acell device failure; that the device performed as expected, that the fascial dehiscence was, in fact, the primary event and that the event resulted from patient factors and inherent patient comorbidities. The acell device was explanted and discarded by the hospital, it is not available for evaluation. A review of the manufacturing records for this lot identified no deviations in the production process. The device was manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures. Acell conducted suture retention testing on the same retained lot which met specification.
 
Event Description
On (b)(6) 2019, acell, inc. Was notified by a surgeon that a patient had a fascial dehiscence with bowel obstruction requiring emergent surgery and hospitalization on (b)(6) 2019. The surgeon observed that the primary sutures used to close the defect had ruptured along with the implanted acell device which had been placed as an underlay. The surgeon informed acell that the patient had been non-complaint with post-operative activity instructions. The surgeon explanted and discarded the acell device. The subsequent repair was completed with a non-acell device, a synthetic mesh. There was no infection present after acell implantation or at acell explantation. The patient developed an infection after implantation of the synthetic mesh.
 
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Brand NameGENTRIX SURGICAL MATRIX PLUS
Type of DeviceGENTRIX SURGICAL MATRIX PLUS
Manufacturer (Section D)
ACELL, INC.
6640 eli whitney dr.
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 Key8405977
MDR Text Key138349783
Report Number3005920706-2019-00003
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model NumberMSPL1015
Device Catalogue NumberMSPL1015
Device Lot Number014449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2018
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: 03/08/2019 Patient Sequence Number: 1
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