MAUDE Adverse Event Report: RESTORELLE Y SHAPED; SURGICAL MESH

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Scarring (2061); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code oto asr exemption # e2014015 for february 2019-march 2019.This mdr is to reflect the additional information to be added to the "intial" asr report (patient information).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code oto asr exemption # e2014015 for february 2019-march 2019.This mdr is to reflect the additional information to be added to the intial asr report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated erosion, infection (uti), dyspareunia, urge incontinence.The mesh was removed.Additional information stated mesh erosion, uti, incontinence, frequency, recurrent cystocele, urge incontinence, cystitis, scarring anterior and posterior, dyspareunia, mild atrophy with extruded posterior vaginal wall mesh along left side of posterior and upper aspect of posterior vaginal wall across (horizontally), thin clear strip of eroded mesh along mi urethra, eroded mesh along left posterior bladder wall with surrounding mucosal erythema and overlaying stone formation.Claim states that the implantation of the mentioned pelvic mesh product occurred on (b)(6) 2005 and also (b)(6) 2010.

Manufacturer Narrative

Patient code 3191 for mild atrophy, mucosal erythema and overlaying stone formation.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE Y SHAPED
• Type of Device: SURGICAL MESH
• MDR Report Key: 9849900
• MDR Text Key: 188372717
• Report Number: 2125050-2020-00259
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 02/25/2019
• Patient Sequence Number: 1