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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product code and lot #? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a gynecological procedure on an unknown date in 2011 and the mesh was implanted.It was reported that the patient had vaginal mesh protrusion at outer aspect of vagina.It was also reported that the mesh protrusion was causing occasional bleeding, and treated with silver nitrate.It was also reported that the patient requests no further intervention but routine 6 monthly follow up.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/5/2021.The following information was requested, but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure? date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product code and lot #? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11392142
• MDR Text Key: 233988568
• Report Number: 2210968-2021-01852
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention