MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Numbness (2415); Blood Loss (2597); No Code Available (3191)

Event Date 09/30/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion code: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2006 and mesh was implanted.The patient experienced multiple erosions of the mesh through the side of the vagina requiring surgical invention and surgical snips of the mesh.On (b)(6) 2016, the patient underwent partial removal of mesh and cystoscopy due to mesh erosion and mesh embedded in the bladder and bowel.Additionally, the patient experienced dyspareunia, pain on top of the vagina/cervix, frequent urinary tract infections, offensive odor from the vagina, persistent bleeding from the vagina, menorrhagia, pain in the right hip radiating into the pelvic and down the right leg to foot, numbness to the right last two last small toes, frequent urination.The patient has experienced a loss of life quality, stress, anxiety and heightened sensitivity to medications and allergens.No additional information was provided.

• Brand Name: GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5588187
• MDR Text Key: 43081410
• Report Number: 2210968-2016-08309
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 1391342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2006
• 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): Required Intervention