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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] pharmacist stated on burn blisters after use of thermacare [burns second degree].Case narrative:the initial case was missing the following minimum criteria: unspecified number of patients.Upon receipt of follow-up information on 02dec2016, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist via a sales representative.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date at an unspecified dose for back.The patient medical history was not reported.The patient's concomitant medications were not reported.The pharmacist stated one female patient applied thermacare for the back.Complaint: burn blisters below the 4 lower heat cells on the left side.Event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device., comment: based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour 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.Reasonably suggest device malfunction: no, severity of harm: n/a.Site sample status: not received.

Event Description

Event verbatim [preferred term] pharmacist stated on burn blisters after use of thermacare [burns second degree].Case narrative:the initial case was missing the following minimum criteria: unspecified number of patients.Upon receipt of follow-up information on 02dec2016, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable pharmacist via a sales representative.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date at an unspecified dose for back.The patient medical history was not reported.The patient's concomitant medications were not reported.The pharmacist stated one female patient applied thermacare for the back.Complaint: burn blisters below the 4 lower heat cells on the left side.Event outcome was unknown.Product investigation results were as follows: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour 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.Reasonably suggest device malfunction: no, severity of harm: n/a.Site sample status: not received.Follow-up (22jan2020): new information reported from pfizer product quality group includes investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 device malfunction has been identified.There is not a product quality related trend identified.No further investigations or actions is suggested at this time.Comment: based on the information provided, the event "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 device malfunction has been identified.There is not a product quality related trend identified.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
• MDR Report Key: 6169294
• MDR Text Key: 62314892
• Report Number: 1066015-2016-00162
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

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: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention