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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 Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Laceration(s) (1946); Pain (1994); Scarring (2061); Complaint, Ill-Defined (2331); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Dysuria (2684)
Event Type  Injury  
Manufacturer Narrative
(b)(6). A review of manufacturing records could not be performed as no lot numbers were provided.
 
Event Description
It was reported to gore in a lawsuit naming 30 other manufacturers that at least one of 94 potential plaintiffs was implanted with a gore pelvic mesh product. The complaint alleges: "after implantation of the subject pelvic mesh products into plaintiffs' bodies, as directed and in accordance with defendants' instructions and specifications, plaintiffs suffered excruciating pain, laceration of internal body tissue and organs, dyspareunia, dysuria, painful and permanent scarring, inability to walk without extreme pain, permanent bodily disfigurement, impairment and damage, related sequelae, and other injuries requiring additional surgeries and corrective treatment. Further injuries suffered by plaintiffs include, but are not limited to, extreme pain and suffering, permanent bodily impairment, mental anguish, and loss of enjoyment of life (collectively referred to as "injuries"). " it was further alleged that "after, and as a result of the implantation of the subject pelvic mesh products, plaintiffs suffered serious bodily injuries, including, but not limited to, extreme pain, erosion of her internal bodily tissue, dyspareunia, painful scarring, additional surgery, and other injuries. " additional, event specific information has not been provided, including which of the 94 plaintiffs were allegedly implanted with a gore device and what gore pelvic mesh product allegedly was implanted. Additional information and medical records have been requested.
 
Manufacturer Narrative
Multiple attempts were made to obtain medical records and additional information regarding the 94 potential plaintiffs. However, no additional information or records were 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
claire west
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key5980986
MDR Text Key55791054
Report Number3003910212-2016-00043
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? 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: 09/27/2016 Patient Sequence Number: 1
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