MAUDE Adverse Event Report: GAYMAR / STRYKER CORP. GAYMAR T/ PUMP PROFESSIONAL K-PAD/HEATING PAD ; PAD, HOT OR COLD, WATER CIRCULATING

Model Number TP700C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/09/2019

Event Type  Injury  

Event Description

Pt using t-pump heating pad and found to have partial thickness burns to back.Fda safety report id# (b)(4).

• Brand Name: GAYMAR T/ PUMP PROFESSIONAL K-PAD/HEATING PAD
• Type of Device: PAD, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): GAYMAR / STRYKER CORP.
• MDR Report Key: 8636652
• MDR Text Key: 146207254
• Report Number: MW5086863
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TP700C
• Device Catalogue Number: TP700C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 95