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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 MSPL0507
Device Problem Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
This mdr is being submitted due to the reported suture pull through that occurred during the initial placement of the acell device. The device was not used, the surgeon decided to close the hernia primarily which resulted in a delay (increased surgery time). The patient did not experience any complication due to the suture pull through. The device was 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 (b)(4) 2019, acell, inc. Became aware that suture pull through occurred with an acell device during the reinforcement of a umbilical hernia repair. The device was not used. The surgeon decided to close the hernia primarily which resulted in a surgical delay (increased surgery time). The patient did not experience any complication due to the suture pull through nor the increased surgery time.
 
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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 Key8659456
MDR Text Key146702556
Report Number3005920706-2019-00010
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00386190001226
UDI-Public(01)00386190001226(17)200731(10)013335
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 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model NumberMSPL0507
Device Catalogue NumberMSPL0507
Device Lot Number013335
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
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: 05/31/2019 Patient Sequence Number: 1
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