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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX Back to Search Results
Model Number PSMX1015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported partial explantation after initial placement of the acell device. The surgeon chose to partially explant to address the recurrent hernia repair not due to a malfunction of the device. The device was not returned to acell for further investigation. 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 12/27/2019, acell, inc. Was notified by a physician that the patient experienced a hernia recurrence. The original surgery in (b)(6) 2019 (exact day unknown) was for an umbilical hernia where the distal to proximal tacking was performed with ethicon securestrap and the acell device. During reoperation in (b)(6) 2019 (exact day unknown) for the recurrent hernia, the physician stated the acell device was partially remodeled and had to be partially explanted to repair the recurrent hernia. Surgeon stated the hernia recurrence occurred due to either contracture retraction or body habitus.
 
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Brand NameGENTRIX SURGICAL MATRIX
Type of DeviceGENTRIX 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 Key9630376
MDR Text Key179546057
Report Number3005920706-2020-00001
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Model NumberPSMX1015
Device Catalogue NumberPSMX1015
Device Lot Number015452
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 Received12/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2019
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: 01/25/2020 Patient Sequence Number: 1
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