MAUDE Adverse Event Report: ETHICON SARL GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PROA1

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

Patient Problems Adhesion(s) (1695); Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Date sent to fda: 05/03/2017.It was reported that the patient underwent gynecological procedure on (b)(6) 2011 and prosiima was implanted concurrently underwent d and c, novasure endometrial ablation and cautery of endometriosis.It was reported that the patient experienced pelvic pain, dyspareunia, adhesions following the procedure.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.

Manufacturer Narrative

It was reported that following insertion the patient experienced urinary tract infection.No additional information was provided.

• Brand Name: GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel NJ 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 4950117
• MDR Text Key: 6253820
• Report Number: 2210968-2015-09905
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: PROA1
• Device Lot Number: 3483009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2010
• 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: 34 YR