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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 Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
Patient Problem Tissue Damage (2104)
Event Date 10/28/2016
Event Type  Injury  
Manufacturer Narrative
The mesh is alleged to be a gore device, however the lot number was not reported. The implant date is not known, but is estimated to be 2007. A review of the manufacturing records could not be conducted because the lot number is unavailable. Gore has requested medical records from the reporter.
 
Event Description
It was reported to gore by the patient's father that his son underwent an appendectomy at age (b)(6) and a large scar remained and four hernias developed in the area. It was reported the son underwent a hernia repair in 2007 in which one alleged gore mesh was used to repair the four hernias. It was further alleged that the gore mesh along with metal staples "came loose and became entangled in the patient¿s intestines. " the patient¿s father reported that on (b)(6) 2016, his son underwent surgery and the alleged mesh was removed along with his intestines and only a foot of the intestines remains.
 
Manufacturer Narrative
According to the report, the patient was scheduled for a follow up visit in (b)(6) 2017 to determine if he was a candidate for intestinal transplant. However, no medical records from the follow up visit were provided. Further communication with the complainant indicated the implanted mesh device was not a gore device. Based on the additional information received indicating this patient was not implanted with a gore device, this medwatch report is being retracted.
 
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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
cheryl hawke
301 airport rd.
elkton, MD 
9285263030
MDR Report Key6449221
MDR Text Key71393873
Report Number3003910212-2017-00017
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
Source Type company representative
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
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: 03/31/2017 Patient Sequence Number: 1
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