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

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent a pelvic floor repair procedure in (b)(6) 2010 and mesh was implanted.The patient complained of pain that had become worse since approximately ten months ago.The pain was relieved by multiple pain medications.The patient experienced dyspareunia, urinary frequency, urgency, and leakage.On exam, there was no evidence of mesh erosion, but the physician was able to trace out the mesh outline submucosally.Palpation on the mesh arms did cause pain, worse on the left side than the right.The patient is status post hysterectomy.The patient underwent a procedure for an explant of mesh in (b)(6) 2013.

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.(b)(4).

• Brand Name: GYNECARE PROLIFT 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3585761
• MDR Text Key: 4165761
• Report Number: 2210968-2014-00578
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2014
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 69