MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Device Problem Fluid/Blood Leak (1250)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 07/18/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] liquid oozed on to my hands causing chemical burns that got worse for several days [chemical burn], even my fingernails were affected [nail disorder], liquid oozed on to my hands [device leakage], liquid oozed on to my hands [accidental exposure to product], i pushed on it to secure [device use error].Case narrative: this is a spontaneous report received from the us fda.The regulatory authority report number was mw5081727.A contactable consumer reported that a patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), from 2016 to an unspecified date at as needed for sore back.The patient medical history and concomitant medications were not reported.The patient stated "i used a thermacare heat wrap across my back.I started to come loose, so i pushed on it to secure on (b)(6) 2016.A liquid oozed on to my hands causing chemical burns that got worse for several days.Even my finger nails were affected on (b)(6) 2016.I took pictures but never reported it." device was not available for evaluation.The events were assessed as other serious (important medical event).Report type was reported as serious injury.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.No follow-up attempts are possible.No further information is expected.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.

Event Description

Event verbatim [preferred term] liquid oozed on to my hands causing chemical burns that got worse for several days [chemical burn] , even my fingernails were affected [nail disorder] , liquid oozed on to my hands [device leakage] , liquid oozed on to my hands [accidental exposure to product] , i pushed on it to secure [device use error] ,.Case narrative:this is a spontaneous report received from the us fda.The regulatory authority report number was mw5081727.A contactable consumer reported that a patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), from 2016 to an unspecified date as needed for sore back.The patient medical history and concomitant medications were not reported.The patient stated "i used a thermacare heat wrap across my back.I started to come loose, so i pushed on it to secure on (b)(6) 2016.A liquid oozed on to my hands causing chemical burns that got worse for several days.Even my finger nails were affected on (b)(6) 2016.I took pictures but never reported it." device was not available for evaluation.The us-fda considered these events to be serious due to important medical event (serious injury).The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No follow-up attempts are possible.No further information is expected.Follow-up (23jan2019): new information received from product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8206592
• MDR Text Key: 131788297
• Report Number: 1066015-2018-00212
• 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: 12/17/2018

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention