MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT+M POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP02

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh 3x was implanted.It was reported that the patient experienced pelvic pain, dyspareunia, difficulty voiding, dysuria, frequency, nocturia, urinary tract infections, erosion and migration, bleeding, scarring and urgency.It was reported that the patient underwent removal surgery on (b)(6) 2014.No additional information was provided.

• Brand Name: GYNECARE PROLIFT+M POSTERIOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12069856
• MDR Text Key: 258497647
• Report Number: 2210968-2021-05828
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFRP02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• 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