MAUDE Adverse Event Report: CARDINAL HEALTH, INC SURE CARE PLUS-UNDERWEAR; GARMENT, PROTECTIVE, FOR INCONTINENCE

Catalog Number 1615A

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

Event Type  malfunction  

Event Description

Adult briefs with bad seems.Manufacturer response for adult diaper, underwear sure care plus (per site reporter).Product failure reported to cardinal's customer service and sales representative by our director of materials management.

• Brand Name: SURE CARE PLUS-UNDERWEAR
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): CARDINAL HEALTH, INC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11705924
• MDR Text Key: 246684728
• Report Number: 11705924
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1615A
• Device Lot Number: 20349G071942
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1