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

Catalog Number PFRT01

Device Problems Material Erosion (1214); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Erosion (1750); Incontinence (1928); Inflammation (1932); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent an anterior vaginal and enterocele repair to treat prolapse and stress incontinence in (b)(6) 2001 and mesh was implanted.In (b)(6) 2002, the stress incontinence was improved but not resolved.The patient experienced urgency of micturition and lower abdominal dragging sensation.In (b)(6) 2002, laxity of the anterior vaginal wall and an inflamed bladder were noted.In (b)(6) 2003, a recurrent cystocele was noted.In (b)(6) 2004, the patient underwent an anterior vaginal repair with surgipro mesh.In (b)(6) 2004, the patient complained of intermittent pain in left iliac fossa and lumber region and a small cystocele and rectocele observed on examination.In (b)(6) 2005, the patient experienced recurrent symptoms of prolapse and urinary issues.A cystocele was observed.In (b)(6) 2005, mesh exposure through vaginal wall was noted and subsequently excised.In (b)(6) 2006, the patient experienced a continuous leakage of urine, nocturia, frequency and was aware of prolapse symptoms and a lump.There was a small mesh erosion noted protruding through the anterior wall and the upper anterior vaginal wall was unsupported.In (b)(6) 2006, mesh was excised.In (b)(6) 2006, the patient complained of pain in the left iliac fossa.No additional information was provided.

Manufacturer Narrative

(b)(4) ¿ prolapse; incontinence occurred.Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3625228
• MDR Text Key: 20861484
• Report Number: 2210968-2014-01533
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2007
• Device Catalogue Number: PFRT01
• Device Lot Number: 2953458
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2006
• 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