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

Catalog Number PFRA01

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

Patient Problems Urinary Retention (2119); Injury (2348); Hematuria (2558); Blood Loss (2597)

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) 2007 and two meshes were implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 8/18/2020.H6 patient code: 1750, 1928, 2120, 3191 - overactive bladder, decreases urine flow, constipation, vaginal vault prolapse, 3189 - surgical intervention.It was reported that the patient underwent revision surgery on (b)(6) 2018 due to mesh erosion.It was reported that the patient experienced blood in urine, vaginal bleeding, overactive bladder, incontinence, urinary retention, decreases urine flow, constipation, uti¿s, and vaginal vault prolapse.

Manufacturer Narrative

Date sent to fda: (b)(6) 2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ANTERIOR PELVIC FLOOR REPAIR S
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9956796
• MDR Text Key: 187515092
• Report Number: 2210968-2020-02988
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Catalogue Number: PFRA01
• Device Lot Number: 3026838
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1