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

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Event verbatim [preferred term] the substance went all over my settee, on the floor, down my husbands trousers and underwear [device leakage] ,.Case narrative:this is a spontaneous report from a non-contactable consumer who reported events for three patients (for her husband, for herself and for her niece) via product quality complaints.This is the first of the three reports and refers to the reporter's husband.Only this case is reportable.A male patient of unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unknown date for back pain.Medical history and concomitant medications were not reported.The reporter bought the lower back and hip wrap for the patient (husband), who was off work with a very painful back.Unfortunately, on the day of the report (09may2016), one of the heat pods had broken whilst the patient was wearing the belt, and the substance went all over the reporter's settee, on the floor, down the patient's trousers and underwear.The reporter at the time following the report was reluctant to use this product again and felt it may be unsafe.All the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it was.The action taken with the suspect product and the outcome of the event was unknown.According to product quality complaints, the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: based on the available information, the report of device leakage was identified during use of the heatwrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available., comment: based on the available information, the report of device leakage was identified during use of the heatwrap.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.This case will be re-assessed should additional information becomes available.

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 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.

Event Description

Event verbatim [preferred term] the substance went all over my settee, on the floor, down my husbands trousers and underwear [device leakage] , all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it was [back pain] ,.Case narrative:this is a spontaneous report from a contactable consumer who reported events for three patients (for her husband, for herself and for her niece) via product quality complaints.This is the first of the three reports and refers to the reporter's husband.Only this case is reportable.A male patient of unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unknown date for back pain.Medical history and concomitant medications were not reported.The reporter bought the lower back and hip wrap for the patient (husband), who was off work with a very painful back.Unfortunately, on 28apr2016, one of the heat pods had broken whilst the patient was wearing the belt, and the substance went all over the reporter's settee, on the floor, down the patient's trousers and underwear.The reporter at the time following the report was reluctant to use this product again and felt it may be unsafe.All the hassle of getting undressed and dressed again had only made the patient's back hurt more as this process was difficult enough as it was.The action taken with the suspect product and the outcome of the events was unknown.According to product quality complaints, the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Additional information received including: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour.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 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.Follow-up (11nov2019): new information received from gsk includes: malfunction assessment and severity ranking.This follow-up report is also being submitted to amend previously reported information: "all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it" was added as an event and code to "back pain aggravated".Follow-up (20nov2019 and 21nov2019): this is a follow-up report combining information from duplicate reports 2019462145 and 2016239139.The current and all subsequent follow-up information will be reported under manufacturer report number 2019462145.The new information reported from a contactable consumer and the product quality complaint group includes updated event onset date and investigational results.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the events of device leakage and back pain aggravated were identified during use of the heatwrap and were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were 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.

Event Description

Event verbatim [preferred term] the substance went all over my settee, on the floor, down my husbands trousers and underwear [device leakage] , all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it was [back pain].Case narrative:this is a spontaneous report from a contactable consumer who reported events for three patients (for her husband, for herself and for her niece) via product quality complaints.This is the first of the three reports and refers to the reporter's husband.Only this case is reportable.A male patient of unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unknown date for back pain.Medical history and concomitant medications were not reported.The reporter bought the lower back and hip wrap for the patient (husband), who was off work with a very painful back.Unfortunately, on (b)(6) 2016, one of the heat pods had broken whilst the patient was wearing the belt, and the substance went all over the reporter's settee, on the floor, down the patient's trousers and underwear.The reporter at the time following the report was reluctant to use this product again and felt it may be unsafe.All the hassle of getting undressed and dressed again had only made the patient's back hurt more as this process was difficult enough as it was.The action taken with the suspect product and the outcome of the events was unknown.According to product quality complaints, the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Additional information received including: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.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 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.Summary of investigation from 13dec2019: a summary investigation was performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient stated the heat cells leaked during product use.There was no burn injury or other serious harm reported.Review of complaint description concludes there is a device malfunction.Severity of harm was s3.Follow-up (11nov2019): new information received from gsk includes: malfunction assessment and severity ranking.This follow-up report is also being submitted to amend previously reported information: "all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it" was added as an event and code to "back pain aggravated".Follow-up (20nov2019 and 21nov2019): this is a follow-up report combining information from duplicate reports (b)(4).The current and all subsequent follow-up information will be reported under manufacturer report number (b)(4).The new information reported from a contactable consumer and the product quality complaint group includes updated event onset date and investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (13dec2019): new information reported from product complaints included investigation results and severity of harm of s3.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the events of device leakage and back pain aggravated were identified during use of the heatwrap and were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were 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.

Manufacturer Narrative

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 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.Summary of investigation from 13dec2019: a summary investigation was performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient stated the heat cells leaked during product use.There was no burn injury or other serious harm reported.Review of complaint description concludes there is a device malfunction.Severity of harm was s3.

Event Description

Event verbatim [preferred term] the substance went all over my settee, on the floor, down my husbands trousers and underwear [device leakage] , all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it was [back pain].Case narrative:this is a spontaneous report from a non-contactable consumer who reported events for three patients (for her husband, for herself and for her niece) via product quality complaints.This is the first of the three reports and refers to the reporter's husband.Only this case is reportable.A male patient of unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unknown date for back pain.Medical history and concomitant medications were not reported.The reporter bought the lower back and hip wrap for the patient (husband), who was off work with a very painful back.Unfortunately, on the day of the report (09may2016), one of the heat pods had broken whilst the patient was wearing the belt, and the substance went all over the reporter's settee, on the floor, down the patient's trousers and underwear.The reporter at the time following the report was reluctant to use this product again and felt it may be unsafe.All the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it was.The action taken with the suspect product and the outcome of the events was unknown.According to product quality complaints, the information in this report was regarded as either involving an event or a malfunction associated with an s3 or greater severity.Additional information received including: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hour.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the events of device leakage and back pain aggravated were identified during use of the heatwrap and were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device.This case will be re-assessed should additional information becomes available.Follow-up (11nov2019): new information received from gsk includes: malfunction assessment and severity ranking.This follow-up report is also being submitted to amend previously reported information: "all the hassle of getting undressed and dressed again had only made the reporter's husband's back hurt more as this process was difficult enough as it" was added as an event and code to "back pain aggravated"., comment: based on the available information, the events of device leakage and back pain aggravated were identified during use of the heatwrap and were assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.The events were assessed as associated with the use of the device.This case will be re-assessed should additional information becomes available.

• 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: 9263322
• MDR Text Key: 220259398
• Report Number: 1066015-2019-00461
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1