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 Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burn in her lumbar zone after using the patch [thermal burn].Narrative: this is a spontaneous report from a consumer received from lp-angelini.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip, lot unknown) on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced burn in her lumbar zone after using the patch.It was reported the patient was polymedicated not sensible to pain.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it 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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.

Event Description

Event verbatim [preferred term] burn in her lumbar zone after using the patch [thermal burn], , narrative: this is a spontaneous report from a consumer received from lp-angelini.A 70-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip, lot unknown) on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced burn in her lumbar zone after using the patch.It was reported the patient was polymedicated not sensible to pain.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality complaint group: 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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Follow-up (05feb2021): new information received from product quality complaint group included: investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: update imdrf code/evaluation result code from c19/213 "no device problem found" to c20/3221 "no findings 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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.

Event Description

Event verbatim [preferred term] burn in her lumbar zone after using the patch [thermal burn], , narrative: this is a spontaneous report from a consumer received from (b)(6).A 70-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip, lot unknown) on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced burn in her lumbar zone after using the patch.It was reported the patient was polymedicated not sensible to pain.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality complaint group: 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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.There is not a product quality-related trend identified for the subclass adverse event/serious/unknown.The manufacturing operations employ quality control procedures, which include in-process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Follow-up (05feb2021): new information received from product quality complaint group included: investigation results.

• 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: 11302016
• MDR Text Key: 230990313
• Report Number: 1066015-2021-00019
• 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
• Report Date: 01/28/2021

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: 02/09/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2021; 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR