MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Use of Device Problem (1670)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Event verbatim [preferred term]: the patch left burns on my skin that are very irritating [thermal burn], the patch left burns on my skin that are very irritating [skin irritation], i used your thermacare product for heat relief for a pinched nerve [device use issue], narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at an unknown dosage for pinched nerve.The patient medical history and concomitant medications were not reported.The patient used the thermacare product for heat relief for a pinched nerve.However, the patch left burns on his/her skin that were very irritating on an unspecified date.The patient mentioned, "please make sure you create a buffer that is stronger on your product so people don't burn their skin".The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].The patch left burns on my skin that are very irritating [thermal burn], the patch left burns on my skin that are very irritating [skin irritation], i used your thermacare product for heat relief for a pinched nerve [device use issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at an unknown dosage for pinched nerve.The patient medical history and concomitant medications were not reported.The patient used the thermacare product for heat relief for a pinched nerve.However, the patch left burns on his/her skin that were very irritating on an unspecified date.The patient mentioned, "please make sure you create a buffer that is stronger on your product so people don't burn their skin".The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality complaint group, this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed as the lot number is unknown.Expedite trend actions taken: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaint intake, triage, and investigation (citi) search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh unknown adverse event/serious (b)(6) 2017 to (b)(6) 2020.No further action required.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.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.A return sample has not been received at the site for evaluation as of 23dec2020.Follow-up (23dec2020): new information received from a product quality complaint group included: investigation results.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There is no device history record (dhr) reviewed for an unknown batch number.A lot trend was not performed as the lot number is unknown.Expedite trend actions taken: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this complaint intake, triage, and investigation (citi) search, there is no trend identified for the subclass of adverse event/serious/unknown.Refer to the 36-month trending chart attachment lbh unknown adverse event/serious (b)(6) 2017 to (b)(6) 2020.No further action required.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.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.A return sample has not been received at the site for evaluation as of 23dec2020.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11089188
• MDR Text Key: 230928460
• Report Number: 1066015-2020-00208
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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
• Patient Outcome(s): Required Intervention