MAUDE Adverse Event Report: GAYMAR T PUMP; TEMP THERAPY SYSTEM/HEAT THERAPY

Model Number TP700

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Tissue Damage (2104)

Event Date 01/23/2016

Event Type  Injury  

Event Description

Heating pad applied directly to skin.Nursing noted redness and blistering consistent with heating pad pattern.From (b)(6) 2016 through (b)(6) 2016.

• Brand Name: T PUMP
• Type of Device: TEMP THERAPY SYSTEM/HEAT THERAPY
• Manufacturer (Section D): GAYMAR
• MDR Report Key: 5416639
• MDR Text Key: 37733189
• Report Number: MW5060036
• Device Sequence Number: 2
• 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: 02/03/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• 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: 4039507
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 103