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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE BIOA TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE BIOA TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number FS2030
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2019
Event Type  Injury  
Manufacturer Narrative
The review of the manufacturing records verified that this lot met all pre-release specifications. The second gore® bio-a® tissue reinforcement will be submitted under medwatch report # 3003910212-2019-00149.
 
Event Description
The patient was implanted with two gore® bio-a® tissue reinforcements on (b)(6) 2016. It was stated that the patient received a vacuum therapy and an ¿abdominal washing¿ prior device implantation. It was stated that the two devices were implanted with direct contact of the bowel followed by a colostomy and vacuum therapy. On (b)(6) 2019, the two gore® bio-a® tissue reinforcements were explanted as it was stated that pieces from the material were rejected.
 
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Brand NameGORE BIOA TISSUE REINFORCEMENT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
barbara ulrich
1500 n. 4th street
9285263030
MDR Report Key8601456
MDR Text Key144758284
Report Number3003910212-2019-00150
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K033671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Model NumberFS2030
Device Catalogue NumberFS2030
Device Lot Number14608476
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2015
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: 05/10/2019 Patient Sequence Number: 1
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