• 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

  • 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 Back to Search Results
Model Number PSMX0710
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 01/09/2020
Event Type  Injury  
Manufacturer Narrative
This mdr is being submitted due to the reported partial explantation three (3) days 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 (b)(6) 2020, acell, inc. Was notified by a physician that the patient experienced a hernia recurrence. The device implantation surgery was a redo laparoscopic hiatal hernia repair with nissen fundoplicationon on (b)(6) 2020. The patient experienced a second hernia recurrence and was reoperated on (b)(6) 2020, when some of the device was partially explanted but the device was otherwise maintained superiorly and medially.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9683892
MDR Text Key188993440
Report Number3005920706-2020-00002
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 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberPSMX0710
Device Catalogue NumberPSMX0710
Device Lot Number018982
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 Received01/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2019
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: 02/07/2020 Patient Sequence Number: 1
-
-