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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
Catalog Number FS2030
Device Problem Material Separation (1562)
Patient Problem Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

Patient information was requested, however no information has been provided. Date of event was requested, however no information has been provided.

 
Event Description

It was reported to gore that a physician was concerned that after one week post implant of a gore® bio-a® tissue reinforcement (item: fs2030) it was not integrating correctly and tearing while in situ. The gore® bio-a® tissue reinforcement was implanted in a patient who had pronounced loss of abdomen. The physician could not get closure and placed the gore® bio-a® tissue reinforcement in the retro rectus plane. The physician decided to explant the material due to it tearing, and it has been saved to be sent back to gore for evaluation.

 
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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
angela brown
1500 n. 4th street
9285263030
MDR Report Key8661179
MDR Text Key146789419
Report Number3003910212-2019-00158
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK033671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue NumberFS2030
Device LOT Number16481570
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2017
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: 06/01/2019 Patient Sequence Number: 1
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