MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS; MESH, SURGICAL, UROGYNECOLOGIC, URINARY INCONTINENCE, MINI-S

Catalog Number 519650

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

During insertion of the single incision sling a portion of sling tore.Surgeon removed and replaced sling with no harm to patient.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, UROGYNECOLOGIC, URINARY INCONTINENCE, MINI-S
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road n; minneapolis MN 55411
• MDR Report Key: 3652685
• MDR Text Key: 4318907
• Report Number: 3652685
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 519650
• Device Lot Number: 3718342
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2014
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 96