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

Catalog Number PROLIFTUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Not Applicable (3189)

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.Note: patient-reported adverse event regarding severe pelvic pain, formed bladder stones and mesh eroded into the bladder ten years later after initial surgery, along with removal of bladder stones and lasered off the bladder wall eroded mesh fibers, was submitted via medwatch 2210968-2019-83389.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and the mesh was implanted.It was also reported that it was unsuccessful from this initial surgery.Some ten years later, the patient experienced severe pelvic pain and following a cystoscopy, the mesh found to be eroded into the bladder and bladder stones had formed.These bladder stones were removed, and eroded mesh fibers were lasered off the bladder wall.Three years later, cystoscopy and hysteroscopy were performed to learn once again that the mesh had severely eroded into bladder and was now close to the right ureter.Bladder stones were also found and removed.The patient was advised to have the total mesh implant removal within the next 12 months and the ureter has to be relocated with two surgeons.No further information is available.

• 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 NJ 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, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8740658
• MDR Text Key: 149394037
• Report Number: 2210968-2019-83390
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

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
• Device Catalogue Number: PROLIFTUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/27/2019
• 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