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

Catalog Number PMM3

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

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 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? other relevant patient history/concomitant medications 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? 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 and results.What is the patient's current status?.

Event Description

It was reported that the patient underwent sacrocolpopexy procedure in (b)(6) 2011 and mesh was implanted.Approximately sixty months following the procedure, the patient experienced vaginal mesh vault erosion.The patient is currently experiencing vaginal discharge but no other significant symptoms.The patient is currently considering treatment options.Additional information has been requested.

• Brand Name: PROLENE POLYPROPYLENE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6941684
• MDR Text Key: 89225955
• Report Number: 2210968-2017-70476
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• 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: HHB939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2017
• Date Device Manufactured: 07/10/2014
• 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