MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Material Erosion (1214)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 the diagnosis and indication for the initial 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.If applicable, will product be returned, return date, tracking information what is 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 a patient underwent a hysteropexy procedure on an unknown date and the mesh was implanted.It was reported that there were findings of foreign body in sigmoid colon, when having routine colonoscopy.It was reported that further examination revealed mesh erosion into the bowel wall with polyp arising from one edge.It was reported that the patient is asymptomatic.It was also reported that the patient was discussed at a colorectal mdt and there is low risk of developing sudden symptoms from rectum point of view.It is also reported that it is important to determine exact height of mesh entry into rectum, because if intraperitoneal, risks are higher, and the patient will need formal bowel resection once rectotomy is made to remove mesh.It was reported that if rectal resection is required there it may be possible to avoid stoma.It was reported that on mri, bowel is adherent to sacral promontory and it appears that it is distal sigmoid on endoscopy with mesh clearly on view; reassuring that it was unchanged on imaging in 2 years.It was reported that the device remains implanted.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10653738
• MDR Text Key: 210681472
• Report Number: 2210968-2020-07773
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: PMM3
• Device Lot Number: JBJ830
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2015
• 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