MAUDE Adverse Event Report: INTCO MEDICAL (HK) COMPANY LIMITED CVS HEALTH INSTANT ICE PACK

Model Number 805-0122-9724

Device Problem Chemical Spillage (2894)

Patient Problems Skin Discoloration (2074); Burning Sensation (2146); Numbness (2415); Partial thickness (Second Degree) Burn (2694)

Event Date 07/15/2015

Event Type  Injury  

Event Description

Per letter from attorney: the end user used the cold back at home, with a towel between the ice pack and his skin, for pain after playing football with his children.The cold pack leaked its interior chemical contents, burning the patient, and seriously injuring him.He sustained second degree burns to his right elbow and forearm, requiring surgical debridement, and thereafter as a direct result developed vitiligo, with discoloration and depigmentation of his right elbow and forearm, the right arm scar neuroma causing burning and stabbing pain and numbness, requiring topical and injected pain killers and extensive rehabilitation.

• Brand Name: CVS HEALTH INSTANT ICE PACK
• Type of Device: INSTANT ICE PACK
• Manufacturer (Section D): INTCO MEDICAL (HK) COMPANY LIMITED; unit 04 7/f bright way tower; no. 33 mong kok road; hong kong, ; HK
• MDR Report Key: 7128107
• MDR Text Key: 95191767
• Report Number: 1422443-2017-00002
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2017

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: Lay User/Patient
• Device Model Number: 805-0122-9724
• Device Catalogue Number: 805-0122-9724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2017
• Distributor Facility Aware Date: 11/16/2017
• Event Location: Home
• Date Report to Manufacturer: 12/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention