RITE AID PAIN RELIEF INSTANT COLD PACK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for RITE AID PAIN RELIEF INSTANT COLD PACK manufactured by .

Event Text Entries

[115576798] Rite aid pain relief instant cold pack is the product description, item number unknown. Lot #: 130413. On (b)(6) 2014 the end-user put on lower back for 1/2 hour then removed then put another one on 6 hours later for 30 minutes. Unknown if product was broken or not. Later that evening developed blisters on his back where the cold pack had been applied. End-user's blisters then popped and appeared inflamed or infected and on (b)(6), presented to his primary care physician for diagnosis and treatment of ruptured blisters. At first it was thought that the blisters were the result of a frost bite, type injury caused by the cold pack, consumer not knowing that the cold pack had actually leaked onto his skin, but were later medically determined to be a chemical burn cause by fluid that had unnoticeably escaped from inside the cold pack during its use, thereby coming into contact with consumer's skin and causing the chemical burns to consumer's lower back. Chemical third degree burn injury wounds became infected and had treatment at an advanced wound care center.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3012316249-2018-00046
• MDR Report Key: 7735749
• Date Received: 2018-07-31
• Date of Report: 2018-07-31
• Date of Event: 2014-04-20
• Date Facility Aware: 2014-06-27
• Report Date: 2018-07-31
• Date Reported to FDA: 2018-07-31
• Date Added to Maude: 2018-07-31
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RITE AID PAIN RELIEF INSTANT COLD PACK
• Generic Name: COLD PACK
• Product Code: IME
• Date Received: 2018-07-31
• Lot Number: 130413
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-07-31