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

Device Problem Device Emits Odor (1425)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.

Event Description

Burn skin [thermal burn], very strong smell [product complaint].Case narrative: this is a spontaneous report from a pfizer sponsored program (b)(6) vine review & response program via product quality complaint group from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced burn skin and very strong smell.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Upon follow-up, product quality complaints provided the following investigation information: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 adverse event safety request for investigation.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Pr state: closed.Additional information received from pqc: severity of harm: s3.Dchu conclusion: based on the complaint narrative, the patient sustained a burn injury after product use.Review of complaint description concludes there is no device malfunction.No follow-up attempts are possible.No further information is expected.Follow-up (13aug2019): new information received from a product quality complaint group includes: investigation information.No follow-up attempts are possible.No further information is expected.Follow-up (13aug2019 and 15oct2019): new information received from a product quality complaint group includes: dchu malfunction and severity assessment.This case was upgraded to a serious and reportable mdr.Company clinical evaluation comment: based on the information provided, the events thermal burn and product complaint as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events thermal burn and product complaint as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE HEATWRAP
• 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: 9444789
• MDR Text Key: 188585867
• Report Number: 1066015-2019-00530
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2019

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: 12/10/2019
• 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