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

Lot Number CM3233

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Heat wrap that a cell brook [device leakage], , narrative: this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had a thermacare heat wrap that a cell brook, he asked if he needed to call a doctor.It only touched the skin on his back, nothing appears to be irritated.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] heat wrap that a cell brook [device leakage], narrative: this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), lot number cm3233, expiration date jul2022, via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had a thermacare heat wrap that a cell brook, he asked if he needed to call a doctor.It only touched the skin on his back, nothing appears to be irritated.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.According to product quality complaint group: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- # hazard analysis thermacare heat wrap product: 8 and 12 hour.The site investigation is in process.Additional information has been requested and will be provided as it becomes available.Follow-up (18may2020 and 19may2020): new information received from product quality complaints group included: suspect product information (lot number, expiration date), severity of harm and impact analysis.

• 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: 10078618
• MDR Text Key: 192152609
• Report Number: 1066015-2020-00121
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Lot Number: CM3233
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1