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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 Material Separation (1562)
Patient Problem Hernia (2240)
Event Date 10/24/2019
Event Type  Injury  
Manufacturer Narrative

Patient age was requested but not provided. The explanted device was returned and the results of the evaluation will be provided in the final report.

 
Event Description

The following was reported to gore: on (b)(6) 2019 a surgeon implanted a gore® bio-a® tissue reinforcement in clean field ventral hernia repair using rives technique. It was reported the patient had a recurrence on (b)(6) 2019. On (b)(6) 2019 the surgeon re-operated on the patient and found that the device was broken in small pieces. The device was removed. A pp mesh was placed and in two days the patient was sent home in good condition. It was further reported the defect size was 3x4 cms on the midline suvra umbilical at the extraction site after robotic prostatectomy. Reportedly, the device was placed retrorectus sublay and was trimmed on 4 corners without reducing size. Additionally, vycril 1/0 was used to close the defect in the posterior fascia. Prolene 2/0 was used at the four corners.

 
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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
cheryl hawke
1500 n. 4th street
9285263030
MDR Report Key9378211
MDR Text Key168430695
Report Number3003910212-2019-00487
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIT
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
Report Date 02/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFS2030
Device Catalogue NumberFS2030
Device LOT Number18833379
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2019
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 Manufactured11/14/2018
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: 11/26/2019 Patient Sequence Number: 1
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