MAUDE Adverse Event Report: COLOPLAST A/S COLOPLAST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLA

Model Number 52081

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Product piece on end (tip) of manipulation was missing.We were able to use the instrument without the piece for this procedure.Product had patient contact but no patient harm.Product was saved and can be returned to the vendor.

• Brand Name: COLOPLAST
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLA
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road n.; minneapolis MN 55418
• MDR Report Key: 7439415
• MDR Text Key: 105782589
• Report Number: 7439415
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/10/2018

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 Model Number: 52081
• Device Lot Number: 5924774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR