MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Lot Number J99339 09/18

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

Patient Problems Pain (1994); Local Reaction (2035)

Event Type  Other  

Event Description

Extremely nasty reaction in the relevant area of her back [local reaction].Case description: this is a spontaneous report from a contactable consumer.An elderly female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare heatwrap, batch/lot # j99339 09/18, expiry: 2017-08 10.02), via an unspecified route of administration from an unspecified date for back pain.Relevant medical history and concomitant medications were not reported.On an unspecified date, the consumer suddenly developed an extremely nasty reaction in the relevant area of her back.Consumer stated that for the last two weeks prior to this report, she had to seek medical advice by visiting her general practitioner/s (gp) on a regular basis to have the dressing renewed.Therapeutic measures taken as a result of event included dressing renewed by her general practitioner/s (gp).The consumer mentioned she had successfully used patches or heat wraps many times to help with bad back pain and they have helped a lot.She never put the patch directly onto the skin, had always adhered strictly to the recommended time limit, had observed the other information given, and had not used them daily.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the event was unknown.

Manufacturer Narrative

Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event "nasty reaction in the relevant area of her back" as described in this case is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017 ; 2127335544
• MDR Report Key: 4763389
• MDR Text Key: 5783266
• Report Number: 1066015-2015-00040
• 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: Foreign,Consumer
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2017
• Device Lot Number: J99339 09/18
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/08/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention