MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC KIT; SURGICAL MESH

Model Number 5195622400

Device Problem Break (1069)

Patient Problem Incontinence (1928)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a patient had a supris implanted on (b)(6) 2018.The patient fell down the stairs and began leaking again and went back to the doc.During the case, it was discovered the sling had snapped and was no longer supporting the urethra.The device was not fully explanted.The physician took as much out as she could, only 2 small pieces.The physician then put a piece of suspend in its place.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.The sling was not returned for evaluation.Without the benefit of analyzing the product, quality cannot confirm any observations and cannot comment on the condition of the device.Based on the information received, the stress caused by the patient falling down the stairs may have contributed to the reported event.If the device becomes available, or additional information is received, quality will re-evaluate this complaint.A review of the contract manufacturer's device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: SUPRIS RETROPUBIC KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8181629
• MDR Text Key: 130920952
• Report Number: 2125050-2018-00893
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195622400
• Device Catalogue Number: 519562
• Device Lot Number: 6181961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other