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 Problems Skin Discoloration (2074); Skin Irritation (2076); Impaired Healing (2378)

Event Type  Injury  

Event Description

Event verbatim [preferred term]: it gave her blisters on her back [blister] , still has a big huge brown spot on her back where the big huge blister was [skin discolouration] , two of the blisters actually stayed and remained active for several weeks and never healed completely [impaired healing].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for lower back pain.The patient's medical history was reported as none.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported the last time she used the heatwraps it gave her huge blisters on her back, right on her waistline where her pants go.So, she has to be very careful how she puts her pants on and stuff like that now.Two of the blisters actually stayed and remained active for several weeks and never healed completely.To this day, she still has a big huge brown spot on her back where the big, huge blister was.The brown spot was further described as an inch and a half round spot that doesn't hurt now.The patient reported she has not consulted a healthcare professional as a result of the events.She stated she put stuff on it herself like neosporin and stuff like that, over the counter stuff and keeping it dry.The patient mentioned she has discarded the product.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the event blister was resolved on an unspecified date.Clinical outcome of the event skin discoloration was not resolved.Clinical outcome of the event impaired healing 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 events of blister, skin discolouration and impaired healing as described is considered serious bodily injury 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., comment: based on the information provided, the events of blister, skin discolouration and impaired healing as described is considered serious bodily injury 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.

Manufacturer Narrative

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 assessment and rationale: a lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] it gave her blisters on her back [blister] , still has a big huge brown spot on her back where the big huge blister was [skin discolouration] , two of the blisters actually stayed and remained active for several weeks and never healed completely [impaired healing].Case narrative:this is a spontaneous report from a contactable consumer.A 52-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for lower back pain.The patient's medical history was reported as none.There were no concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported the last time she used the heatwraps it gave her huge blisters on her back, right on her waistline where her pants go.So, she has to be very careful how she puts her pants on and stuff like that now.Two of the blisters actually stayed and remained active for several weeks and never healed completely.To this day, she still has a big huge brown spot on her back where the big, huge blister was.The brown spot was further described as an inch and a half round spot that doesn't hurt now.The patient reported she has not consulted a healthcare professional as a result of the events.She stated she put stuff on it herself like neosporin and stuff like that, over the counter stuff and keeping it dry.The patient mentioned she has discarded the product.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the event blister was resolved on an unspecified date.Clinical outcome of the event skin discoloration was not resolved.Clinical outcome of the event impaired healing was unknown.According to product quality complaints, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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 assessment and rationale: a lot trend was not performed as the lot number is unknown.Follow-up (06mar2019): follow-up attempts are completed.No further information is expected.Follow-up (09apr2020): new information reported from product quality complaints included: investigation result.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of blister, skin discolouration and impaired healing as described is considered serious bodily injury 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 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: 7359226
• MDR Text Key: 103146645
• Report Number: 1066015-2018-00038
• 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
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR