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

Model Number 5195621022

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 08/16/2019

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 retropubic sling was implanted in a patient on approximately three and a half months post expiration date.The product was on consignment with the hospital.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.As the product remains implanted, and no further information has been received, it was concluded that no further action is required at this time.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.

• 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: 9100354
• MDR Text Key: 159426923
• Report Number: 2125050-2019-00772
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K053296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5195621022
• Device Catalogue Number: 519562
• Device Lot Number: 5076138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other