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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES UNKNOWN

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W.L. GORE & ASSOCIATES UNKNOWN Back to Search Results
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Hernia (2240); Not Applicable (3189)
Event Date 09/25/2014
Event Type  Injury  
Manufacturer Narrative

(b)(6). It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. ¿ ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿.

 
Event Description

It was reported to gore that the patient underwent a type unknown hernia repair on an unknown date in 2008, whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: removal of mesh, hernia recurrence, additional surgery. Additional event specific information was not provided.

 
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Brand NameUNKNOWN
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
marcos ayala
1500 n. 4th street
9285263030
MDR Report Key8376478
MDR Text Key137363741
Report Number3003910212-2019-00040
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/27/2019 Patient Sequence Number: 1
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