MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number BK2631

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] had the heat cells open [device leakage], , narrative: this is a spontaneous report from a contactable consumer (patient).This consumer reported two devices.This is the second of 2 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number bk2631, expiration date jan2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient opened thermacare backpain therapy l/xl.One of the wraps was had the heat cells open.The action taken in response for the event and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].Had the heat cells open [device leakage], , narrative: this case is invalid due to being the non-retained duplicate of aer# 2021161030.This is a spontaneous report from a contactable consumer (patient).This consumer reported two devices.This is the second of 2 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number bk2631, expiration date jan2023, via an unspecified route of administration from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient opened thermacare backpain therapy l/xl.One of the wraps was had the heat cells open.The action taken in response for the event and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (11feb2021): this case is being deleted from the database for the following reason: duplicate case.This is a follow-up report to notify that cases (b)(4) are duplicates.All subsequent information will be reported under manufacturer report number 2021161030.No follow-up attempts are needed.No further information is expected.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11401505
• MDR Text Key: 280460924
• Report Number: 1066015-2021-00025
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Lot Number: BK2631
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1