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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

: initial reporter's complete address - (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 59 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 59 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 59 potential plaintiffs.However, no additional information or records were provided.(b)(4).

• Brand Name: UNKNOWN
• 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 Key: 5730803
• MDR Text Key: 47592547
• Report Number: 3003910212-2016-00029
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Other