MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Blood Loss (2597); Not Applicable (3189)

Event Date 07/04/2018

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, gender, weight, bmi at the time of index procedure.The diagnosis and indication 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 medical/surgical intervention for exposure including dates.Please provide the date of reoperation.What were the findings on reoperation? were any deficiencies or anomalies noted with mesh device? are there any pictures available for evaluation? product code and lot #.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent a laparoscopic rectopexy and sacrocolpopexy procedure on (b)(6) 2018 and the mesh was implanted.The patient complicated due to rheumatoid arthritis, steroids, methotrexate and low bmi (15).Following recovery and discharge, the patient was readmitted with pr bleeding.It was found that the patient has a complete breakdown of anterior rectal wall with mesh exposed.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Additional information was requested, and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure na the diagnosis and indication for the index surgical procedure? (b)(4) 2018 any concurrent procedure/device implantation? na were there any intra-operative complications? na when was the mesh exposure first noted by a physician? (b)(4) 2018 mesh exposure site/location, symptoms and diagnostic confirmation? na describe medical/surgical intervention for exposure including dates.Please provide the date of reoperation.(b)(4) 2018 what were the findings on reoperation? patient had laparoscopic mesh rectopexy and lap sacro-colpopexy by colorectal and gynae on (b)(4) 2018.Patient complicated due to rheumatoid arthritis, steroids, methotrexate and low bmi ((b)(4)).Following recovery and discharge was readmitted with pr bleeding - found to have complete breakdown of anterior rectal wall with mesh exposed.Were any deficiencies or anomalies noted with mesh device? are there any pictures available for evaluation? na product code and lot # na what is the physician¿s opinion as to the etiology of or contributing factors to this event? na what is the patient¿s current status? na.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7818947
• MDR Text Key: 118305646
• Report Number: 2210968-2018-75446
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2018
• 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 Outcome(s): Required Intervention