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

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.

Event Description

Event verbatim [preferred term] red eyes [ocular hyperaemia], a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product], started coughing [cough], something trickled out of it (active component, amongst others iron powder) [device leakage].Case narrative: this is a spontaneous lay media report published in a newspaper "bild duesseldorf" which was reported by a contactable consumer via local department.This newspaper article reported same events for 3 patients.This is the second of 3 reports.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported that three guests of a bar suddenly had red eyes and started coughing.The cause: a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).The ambulance and an emergency physician arrived.The heat patch was hermetically wrapped, the guests of the bar were examined and brought to a hospital as a precaution.The outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/ leaking.The 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.Severity rank: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (10 feb 2017): follow-up attempts completed.No further information expected.Follow-up (11 oct 2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (14 dec 2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the events red eyes and coughing allegedly "something trickles out of heatwrap (active component, amongst others iron powder)" were considered serious medical conditions requiring intervention to preclude serious outcome.A causal relationship between the suspect device and the events cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for  evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the available information, the events red eyes and coughing allegedly "something trickles out of heatwrap (active component, amongst others iron powder)" were considered serious medical conditions requiring intervention to preclude serious outcome.A causal relationship between the suspect device and the events cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

Event verbatim [preferred term] red eyes [ocular hyperaemia] , a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product] , started coughing [cough] , something trickled out of it (active component, amongst others iron powder) [device leakage].Case narrative:this is a spontaneous lay media report published in a newspapaer "bild duesseldorf" which was reported by a contactable consumer via local department.This newspaper article reported same events for 3 patients.This is the second of 3 reports.A patient of unspecified age and gender started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The consumer reported that three guests of a bar suddenly had red eyes and started coughing.The cause: a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).The ambulance and an emergency physician arrived.The heat patch was hermetically wrapped, the guests of the bar were examined and brought to a hospital as a precaution.The outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The 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.Severity rank: s3.Follow-up (10feb2017): follow-up attempts completed.No further information expected.Follow-up (11oct2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (14dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (16dec2019): this follow-up report is being submitted as a final reportable mdr., comment: based on the available information, the events red eyes and coughing allegedly "something trickles out of heatwrap (active component, amongst others iron powder)" were considered serious medical conditions requiring intervention to preclude serious outcome.A causal relationship between the suspect device and the events cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass heat cells damaged/leaking.The 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.Severity rank: s3.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9257385
• MDR Text Key: 182000389
• Report Number: 1066015-2019-00284
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

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: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention