MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

One of the cells was punctured.[device leakage], , narrative: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on (b)(6) 2020, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient stated none of the heatwraps activated.And one of the cells was punctured on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the event was unknown.Product complaint group determined this complaint to be a reportable for device leakage.Additional information has been requested and will be provided as it becomes available., comment: based on the available information, the patient reported that one of the cells was punctured.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The events are medically assessed as associated with the use of the device.The company is conducting further review on this investigation and additional follow-up will be reported when the evaluation is completed.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 10005371
• MDR Text Key: 190505060
• Report Number: 1066015-2020-00106
• 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
• Report Date: 01/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1