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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Neuralgia (4413)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure on an unknown date in 2010 and the mesh was implanted.It was reported that the patient experienced erosion and some neuralgia.Additional information was requested.

Manufacturer Narrative

(b)(4).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, gender, weight, bmi at the time of index procedure date, name, and initial approach for the index surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient history/ concomitant medications? any concurrent procedure/ device implantation? were there any intra-operative complications? when was the mesh exposure and neuralgia first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure and neuralgia including dates and surgical findings.Product lot #? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

• 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 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13006225
• MDR Text Key: 284281801
• Report Number: 2210968-2021-12606
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female