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

Device Problem Leak/Splash (1354)

Patient Problems Red Eye(s) (2038); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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.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 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 of harm: s3.

Event Description

A tourist had left his heat patch ("thermacare") and something trickled out of it (active component, amongst others iron powder).[accidental exposure to product], red eyes [ocular hyperaemia], started coughing [cough], heat patch ("thermacare") and something trickled out of it [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 first 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.Action taken with thermacare heatwrap and the outcome of the events was unknown.Product quality complaints group provided followings: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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.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 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 of harm: s3.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.Follow-up (11-nov-2019): new information received from product quality complaints (pqc) group included: severity of harm was assessed as s3.Follow-up (18-nov-2019): new information received from product quality complaints group included: product updated from thermacare heatwrap to thermacare lower back & hip, summary of investigation, and conclusion.Follow-up attempts are completed.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.

• 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
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9401428
• MDR Text Key: 187589567
• Report Number: 1066015-2019-00494
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• 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: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention