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

Device Problems Unintended Ejection (1234); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Event verbatim [preferred term] thermacare back warmer, it burst, it ruined my clothes [device leakage] ,.Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number and device expiration date was not provided) from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced "i had a thermacare back warmer, it burst, it ruined my clothes" on an unspecified date.Consumer received a letter, instructions to send back the thermacare heatwrap and (courier company name) bag.Consumer stated "even though my clothes are ruined, i am not going to send anything back so you can all just close this complaint.I do not have it.It was thrown away." the consumer explained, "i borrowed this thermacare heatwrap from a person and i told him to hold on to it for a week but he threw it away so i don't have it to send to you.I am done talking to all of you, please close the reference number and the complaint number." the action taken with thermacare heatwrap and the outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient reported that thermacare back warmer, it burst, it ruined my clothes.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device per (b)(4) (a causal relationship cannot be ruled out).The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed., comment: based on the available information, the patient reported that thermacare back warmer, it burst, it ruined my clothes.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device per (b)(4) (a causal relationship cannot be ruled out).The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed.

Event Description

Event verbatim [preferred term] thermacare back warmer, it burst, it ruined my clothes [device leakage].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number and device expiration date was not provided) from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced "i had a thermacare back warmer, it burst, it ruined my clothes" on an unspecified date.The patient received a letter, instructions to send back the thermacare heatwrap and (courier company name) bag.The patient stated "even though my clothes are ruined, i am not going to send anything back so you can all just close this complaint.I do not have it.It was thrown away." the patient explained, "i borrowed this thermacare heatwrap from a person and i told him to hold on to it for a week but he threw it away so i don't have it to send to you.I am done talking to all of you, please close the reference number and the complaint number." the action taken with thermacare heatwrap and the outcome of the event was unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up(18nov2019): new information received from the product quality complaint group includes malfunction assessment and severity rating.No follow up attempts are possible.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that thermacare back warmer, it burst, it ruined my clothes.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device per ser060 (a causal relationship cannot be ruled out)., comment: based on the available information, the patient reported that thermacare back warmer, it burst, it ruined my clothes.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device per ser060 (a causal relationship cannot be ruled out).

Manufacturer Narrative

Class/sub class: mixed product | pfizer product mixed with another product from a different site.Complaint confirmed unique: not confirmed.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, 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 pfizer product mixed with another product from a different site.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.Pfizer does not manufacture dearfoams product.The description of the material leaking from the device being described as stiff from wax, would not be a thermacare wrap, no material used in manufacturing of thermacare would cause clothes' to be stiff from wax if contents leaked.The mix did not occur at the site because the "wrap" described would not pass through the site's packing system.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.A return sample has not been received at the site for evaluation as of (b)(6) 2020.

Event Description

Event verbatim [preferred term] box is a thermacare box, but the wrong product is in the thermacare box.[no adverse event], , narrative: this case has been considered invalid since there is no indication that the consumer experienced an event or allege any deficiency with thermacare, just a product complaint.The previously reported leakage occurred on a non-pfizer product.This is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number and device expiration date was not provided) from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced "i had a thermacare back warmer, it burst, it ruined my clothes" on an unspecified date.The patient received a letter, instructions to send back the thermacare heatwrap and (courier company name) bag.The patient stated "even though my clothes are ruined, i am not going to send anything back so you can all just close this complaint.I do not have it.It was thrown away." the patient explained, "i borrowed this thermacare heatwrap from a person and i told him to hold on to it for a week but he threw it away so i don't have it to send to you.I am done talking to all of you, please close the reference number and the complaint number." the action taken with thermacare heatwrap and the outcome of the event was unknown.According to the product quality complaint group: reasonably suggest device malfunction was yes and severity of harm was s3.Follow-up (18nov2019): new information received from the product quality complaint group includes malfunction assessment and severity rating.No follow up attempts are possible.No further information is expected.Follow-up (21nov2019): no follow up attempts are possible.No further information is expected.Follow-up (08jul2020): this is a follow-up spontaneous report received from a product quality complaints group.This report included: date of contact 21-oct-2019: description of complaint: caller calling about product provided as thermacare heatwrap.Attempted to clarify product name further she stated it was for the back, back warmer by (company name).Caller stated she used it for the first time this weekend.She placed it in the microwave for two minutes, but it was not at the right temperature.She then added it back to the microwave for another minute and it was fine.It was the right temperature and she loved it.The following day she used it again and this time she put it in for three minutes from the beginning.She placed the product in the pouch thing and she put it on her back.She had jeans and a shirt on.She really liked it.She did not have a jacket on.After it was on she started to feel like it was wet and saw it was dripping so she took it off.Her shirt has a huge thing on it, like it is stiff from wax that has hardened or something.Her pants are also hardened.She cannot use this product anymore it is ruined.Her clothes are ruined.Stated her back is fine now.Before it was red, but she is okay now.She confirmed she used the same wrap twice.It only came with one in the package.It was a thick thing that goes into the pouch and then wrap around her body.Stated she did not hurt herself.Her back was red for only half an hour then she was fine.It was just a little red.Stated she did not burn herself.Stated she had the heated thing in the a pouch and had a shirt on.Stated the only thing that was not fine was her clothing.She wanted to know if she could wash her clothes or find out if they are beyond repair.She does not just want to throw them in the machine and wash them because does not want to ruin other clothes.She confirmed she no longer has the box she just has the instruction booklet and she took a picture of the thing that went into the microwave.Stated from the picture only number she can provide is: paa.Later in call she provided and confirmed manufacturer as pfizer.22oct2019: follow-up/duplicate received under pr #: description of complaint: new info: box is a thermacare box, but the wrong product is in the thermacare box.She doesn't have the box with her at this time, but she wrote our phone number down from the box.Caller states when she put the heat warmer into the pouch after microwaving it, it leaked on her clothes.She asks if she can wash her clothes now? caller insists this is a thermacare product.New: she is reading the heat warmer, and it says from (company name) by (company name).She states someone put the wrong product in the thermacare box.She will get the box and call us back with the lot number.Class/sub class: mixed product | pfizer product mixed with another product from a different site.Complaint confirmed unique: not confirmed.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, 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 pfizer product mixed with another product from a different site.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.Pfizer does not manufacture dearfoams product.The description of the material leaking from the device being described as stiff from wax, would not be a thermacare wrap, no material used in manufacturing of thermacare would cause clothes' to be stiff from wax if contents leaked.The mix did not occur at the site because the "wrap" described would not pass through the site's packing system.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.A return sample has not been received at the site for evaluation as of 19jun2020.No follow-up attempts are possible.No further information is expected.

• 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: 9354439
• MDR Text Key: 220293061
• Report Number: 1066015-2019-00482
• 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,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/21/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2019; 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1