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

Device Problem Leak/Splash (1354)

Patient Problem Red Eye(s) (2038)

Event Type  Injury  

Event Description

Event verbatim [preferred term] red eyes [ocular hyperaemia], started coughing [cough], something trickled out of it (active component, amongst others iron powder) [device leakage], a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product].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 similar events for 3 patients.This is the third of 3 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.It was reported that three guests of a bar suddenly had red eyes and started coughing.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 action taken with thermacare heatwrap and the outcome of the events was unknown.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 (14 dec 2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.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.This case will be re-assessed should additional information becomes available.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.This case will be re-assessed should additional information becomes available.

Event Description

Red eyes [ocular hyperaemia], started coughing [cough], something trickled out of it (active component, amongst others iron powder) [device leakage], a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product].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 similar events for 3 patients.This is the third of 3 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.It was reported that three guests of a bar suddenly had red eyes and started coughing.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 action taken with thermacare heatwrap and the outcome of the events was unknown.Additional information received from product quality complaint group included: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Follow-up (10feb2017): follow-up attempts completed.No further information expected.Follow-up (14dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from product quality complaint group included: impact analysis and severity ranking.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.This case will be re-assessed should additional information becomes available., 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.This case will be re-assessed should additional information becomes available.

Event Description

Red eyes [ocular hyperaemia], started coughing [cough], something trickled out of it (active component, amongst others iron powder) [device leakage], a tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product].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 similar events for 3 patients.This is the third of 3 reports.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.It was reported that three guests of a bar suddenly had red eyes and started coughing.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 action taken with thermacare heatwrap and the outcome of the events was unknown.Additional information received from product quality complaint group included: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.According to product quality complaint group, conclusion: 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 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.Follow-up (10feb2017): follow-up attempts completed.No further information expected.Follow-up (14dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (11nov2019): new information received from product quality complaint group included: impact analysis and severity ranking.Follow-up (21nov2019): new information received from product quality complaint group included: suspect product updated from thermacare heatwrap to thermacare lower back & hip and investigation results.No follow-up attempts are needed/possible.No further information is expected., 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.No further investigations or actions 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 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.

• 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: 9257389
• MDR Text Key: 181999377
• Report Number: 1066015-2019-00286
• 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,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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention