MAUDE Adverse Event Report: PFIZER, INC. PACK, HOT OR COLD, DISPOSABLE; THERMACARE HEATWRAPS

Lot Number DP0465

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2022

Event Type  malfunction  

Event Description

I opened two thermacare heat wraps and both had leaked fluid.Neither expired until 2023.I got fluid on my hands and had to contact a physician to ensure that rinsing was ok, since the instructions say to get professional help.Fda safety report id# (b)(4).

• Brand Name: PACK, HOT OR COLD, DISPOSABLE
• Type of Device: THERMACARE HEATWRAPS
• Manufacturer (Section D): PFIZER, INC.
• MDR Report Key: 13236513
• MDR Text Key: 283777839
• Report Number: MW5106585
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2023
• Device Lot Number: DP0465
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic