MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y; SURGICAL MESH

Model Number	5014302400
Medical Device Problem Codes	Positioning Failure (1158); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Internal Organ Perforation (1987); Urinary Retention (2119); Urinary Tract Infection (2120); Hyporesponsive to stimuli (2683); Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced incomplete emptying, bladder outlet obstruction, incontinence, stress urinary incontinence, recurrent urinary tract infections, bladder perforation of sacrocolpopexy device.Patient had a midurethral device implanted for severe stress urinary incontinence.Patient had a cystoscopy and it revealed erosion and/or perforation of sacrocolpopexy device through the bladder wall in the posterior bladder wall with multiple skin bridges on the posterior bladder wall.Patient had a urodynamic study performed and it revealed a very large bladder capacity with decreased sensation.Patient was unable to void for the study, and her residual was 560 ml.Patient had an mri and it revealed bladder perforation of sacrocolpopexy device.Patient had robotic explantation of the sacrocolpopexy device, cystotomy repair, cystoscopy with bilateral ureteral stent placement, explantation of transvaginal midurethral device and cystoscopy under general anesthesia.Intraoperative notes indicated that the sacrocolpopexy device had been fixed to the bladder itself, and the plane between the bladder and the vagina had not been dissected properly.The device was covering the posterior peritoneum covering the vagina, and the anterior limb of the device was completely sutured to the posterior bladder wall and not providing significant support.The device was creating a kink over the urethra and the distal urethra was bulging beyond the position of the device, confirming the obstructive nature of the placement of the device.

• Brand Name: RESTORELLE Y
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16147413
• Report Number: 2125050-2022-01474
• Device Sequence Number: 6866962
• Product Code: OTO
• UDI-Device Identifier: 05708932483896
• UDI-Public: 05708932483896
• Combination Product (Y/N): N
• PMA/510(K) Number: K112322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2017
• Device Model Number: 5014302400
• Device Catalogue Number: 501430
• Device Lot Number: 4132746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/12/2023
• Date Device Manufactured: 06/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown