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

Event verbatim [preferred term] used patch over night and had a burn blister the next morning [burns second degree], , narrative: this is a spontaneous report from a contactable consumer (patient).This is a report based on information received by pfizer from license partner angelini pharma, license party for thermacare heatwrap.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient used patch over night and had a burn blister the next morning on an unspecified date.She had experience with thermacare, and could not provide the batch number.The action taken in response to the event for thermacare heatwrap and event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] used patch over night and had a burn blister the next morning [burns second degree], , narrative: this is a spontaneous report from a contactable consumer (patient).This is a report based on information received by pfizer from license partner (b)(6), license party for thermacare heatwrap.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient used patch overnight and had a burn blister the next morning on an unspecified date.She had experience with thermacare and could not provide the batch number.The action taken in response to the event for thermacare heatwrap and event outcome was unknown.According to product quality group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burn blisters.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.Follow-up (08feb2021): follow-up attempts completed.No further information expected.Follow-up (05feb2021): new information received from product quality group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burn blisters.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

Event Description

Event verbatim [preferred term] used patch over night and had a burn blister the next morning [burns second degree], , narrative: this is a spontaneous report from a contactable consumer (patient).This is a report based on information received by pfizer from license partner (b)(4), license party for thermacare heatwrap.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient used patch overnight and had a burn blister the next morning on an unspecified date.She had experience with thermacare and could not provide the batch number.The action taken in response to the event for thermacare heatwrap and event outcome was unknown.According to product quality group: conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burn blisters.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.Follow-up (08feb2021): follow-up attempts completed.No further information expected.Follow-up (05feb2021): new information received from product quality group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (18feb2021): follow-up attempts are completed.No further information is expected.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

The root cause category is non-assignable (complaint not confirmed as a quality defect).Limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.No product quality related trend identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burn blisters.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

• 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: 11285715
• MDR Text Key: 234392684
• Report Number: 1066015-2021-00018
• 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: 02/05/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2021; 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention