MAUDE Adverse Event Report: GAYMAR INDUSTRIES AQUA K PAD/PUMP; HEATER COOLER

Model Number TP700

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 05/04/2015

Event Type  Injury  

Event Description

(b)(6) female, adhesives and latex allergies: history of: arthritis, chf, asthma, gerd, htn, thyroid disease, dmii, had cystoscopy, bilat retrogrades and stent placement.Flank pain post op.Starting using the heating pad (not covered by anything, directly on skin).Was on pain meds.Pt states she woke up the next morning and pad was still on her back.States she noted when she removed heating pad it was stuck to her skin.Later when she returned home, she shares her spouse noted that she had red strips across her back.She states they were red and blistered.She states her daughter who is a nurse looked at them and told her it was a burn.

• Brand Name: AQUA K PAD/PUMP
• Type of Device: HEATER COOLER
• Manufacturer (Section D): GAYMAR INDUSTRIES
• MDR Report Key: 4856401
• MDR Text Key: 5807338
• Report Number: MW5043142
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TP700
• Other Device ID Number: 403484008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 86