• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ACELL, INC. GENTRIX SURGICAL MATRIX THIN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure to Anastomose (1028)
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported anastomotic leak after initial placement of the acell device. The acell device was explanted; however it is not available for evaluation. A review of the manufacturing records is not possible as the acell device, lot and serial number was not provided by the surgeon. Nevertheless, all acell devices are manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures. We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.
 
Event Description
On (b)(6) 2019, acell, inc. Was notified by a physician that their patient developed an anastomotic leak and became septic, four (4) days after performing an anastamosis repair wrapped with an acell gentrix device. The surgeon was unable to provide the date of the surgery and the acell device used. We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8745294
MDR Text Key149546176
Report Number3005920706-2019-00013
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/01/2019
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: 06/28/2019 Patient Sequence Number: 1
-
-