MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; PACK, HOT OR COLD, DISPOSABLE

Model Number 16-9706

Device Problems Protective Measures Problem (3015); Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Blister (4537)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Abrasion/blistered noted on patient's back.Patient reports it was from a heat pack two days prior.Hot pack slipped out of cloth and patient fell asleep.No weeping or bleeding noted.Usually the heat pack does not slip out of the cloth if it is wrapped in.

• Brand Name: MCKESSON
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 9954 mayland dr; richmond VA 23233
• MDR Report Key: 13691825
• MDR Text Key: 286745063
• Report Number: 13691825
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2022

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 Model Number: 16-9706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13505 DA
• Patient Sex: Female