MAUDE Adverse Event Report: COLOPLAST CORP ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Leak/Splash (1354)

Patient Problem Urinary Retention (2119)

Event Date 04/09/2019

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.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 Description

According to the available information, the patient underwent revision for reported leaking and retention.In the or, the sling was loosened to a small space between the graft and urethra.No leakage was then reported, and the physician closed the incision with less tensioning than was expected.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8593112
• MDR Text Key: 144519023
• Report Number: 2125050-2019-00345
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR