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

Catalog Number PFRA01

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Incontinence (1928); Pain (1994)

Event Type  Injury  

Event Description

It is reported in the intimation of claim that the complainant underwent a pelvic floor repair procedure on (b)(6) 2009 and a mesh was implanted.The patient underwent further procedures on (b)(6) 2009 and on (b)(6) 2010 and mesh devices were implanted.Following the surgery she has experienced intense pain in her vagina and back passage and continued to suffer problems with incontinence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE PROLIFT ANTERIOR 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 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4785785
• MDR Text Key: 5799250
• Report Number: 2210968-2015-06101
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

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: 09/30/2011
• Device Catalogue Number: PFRA01
• Device Lot Number: 3222412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2008
• 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
• Patient Age: 50 YR