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

Model Number 1615A

Device Problems Product Quality Problem (1506); Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

Adult diapers have bad seams and fall apart.Manufacturer response for adult diaper, underwear sure care plus (per site reporter).Product failure was reported to cardinal's customer service.

• Brand Name: SURE CARE PLUS PROTECTIVE UNDERWEAR
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street building 5; mansfield MA 02048
• MDR Report Key: 11434938
• MDR Text Key: 238346471
• Report Number: 11434938
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1615A
• Device Catalogue Number: REF 1615A
• Device Lot Number: 20349G071942
• 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: 03/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1