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

Catalog Number PMM1

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Inflammation (1932); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 06/01/2017.(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.

Event Description

It was reported that the patient underwent an open sacrocolpopexy on (b)(6) 2011 and the mesh was implanted.The procedure and recovery were uneventful six months post operatively.In (b)(6) 2016, the patient was presented with vaginal discharge as her main symptom only and a mesh erosion at the vaginal vault was discovered along with confirmed surrounding inflammation on imaging.The patient underwent a laparoscopic excision of the mesh on (b)(6) 2017 completely removing this from the vaginal vault.The procedure is uneventful with good recovery.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 NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6604846
• MDR Text Key: 76430887
• Report Number: 2210968-2017-32359
• 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
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TVT
• Patient Outcome(s): Required Intervention