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

Catalog Number	1615A
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): CARDINAL HEALTH, INC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11705924
• Report Number: 11705924
• Device Sequence Number: 13498167
• Product Code: EYQ
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021
• Report Date (Section F): 04/19/2021

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
• Operator of Device: No Information
• Device Catalogue Number: 1615A
• Device Lot Number: 20349G071942
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/19/2021