MAUDE Adverse Event Report: COLOPLAST A/S HOLTEDAM / COLOPLAST MANUFACTURING US, LLC ALTIS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Catalog Number 5196502400

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

During bladder sling insertion of product altis batch code 7203149, catalog number 5196502400.Item was broke when surgeon went to place sling.Fda safety report id # (b)(4).

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST A/S HOLTEDAM / COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 10919174
• MDR Text Key: 218978953
• Report Number: MW5098132
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2020

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: Health Professional
• Device Expiration Date: 03/23/2023
• Device Catalogue Number: 5196502400
• Device Lot Number: 7203149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 89