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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Pain (1994); Not Applicable (3189)

Event Date 03/21/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure.Date of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications.Product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? onset date/time of the pain from surgery.Location and character of the pain? what medical intervention was given for the pain management? results? please provide the date and results of the partial mesh excision.What is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown surgical procedure in 2011 and the mesh was implanted.The patient developed vaginal pain and required mesh excision.Since then the patient underwent a colposuspension/ revision procedure due to stress incontinence and the symptoms of pain are improved.The device was partially excised.Additional information has been requested.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7095797
• MDR Text Key: 94119253
• Report Number: 2210968-2017-71656
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• 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