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U.S. Department of Health and Human Services

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

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ACELL, INC. GENTRIX SURGICAL MATRIX THIN Back to Search Results
Model Number PSM0412
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported seroma formation after initial placement of the acell device. It is unknown when the acell device was implanted and if it was explanted. The device is not available for evaluation. A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.
 
Event Description
On 3/6/2019, acell, inc. Was notified by a surgeon that a patient experienced a seroma post operative after a hiatal hernia repair procedure with an acell device, date of procedure was not provided. The patient required reoperation for other reasons; it is unknown if the reoperation was related to the seroma. Surgeon used the acell device prophylactically on a midline laparotomy closure; the laparotomy was created to perform hiatal hernia repair but not used to reinforce the hiatus. The surgeon prefers to insert the device in the valley of the defect and then close the subcutaneous flap.
 
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Brand NameGENTRIX SURGICAL MATRIX THIN
Type of DeviceGENTRIX SURGICAL MATRIX THIN
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 Key8484988
MDR Text Key141018869
Report Number3005920706-2019-00004
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Model NumberPSM0412
Device Catalogue NumberPSM0412
Device Lot Number010293
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 Received03/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2017
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: 04/04/2019 Patient Sequence Number: 1
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