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

Catalog Number PFRP02

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) 2011 and two (2) mesh products were implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 2/27/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 4/17/2022.H6: appropriate term / code not available (e2402) utilized to capture tissue granulation, urinary hesitancy additional b5 narrative: it was reported that the patient experienced tissue necrosis and granulation, erosion and urethral obstruction following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2020 due to frequent infections, urinary hesitancy and intermittent pain.

• 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: 13529755
• MDR Text Key: 287430626
• Report Number: 2210968-2022-01046
• 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,Followup,Followup
• Report Date: 02/14/2022

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: 08/31/2013
• Device Catalogue Number: PFRP02
• Device Lot Number: 3512143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/23/2022; 04/17/2022
• Supplement Dates FDA Received: 02/27/2022; 04/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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: 70 YR
• Patient Sex: Female