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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Itching Sensation (1943)

Event Type  Injury  

Event Description

Burned me enough to peel off my skin [thermal burn], burned me enough to peel off my skin [skin exfoliation], itch [pruritus], the pads must be stretched tight to fit [product size issue].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (no lot number or expiration date provided) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported "the new pads are disappointing.Even though i am a woman who usually wears xs to small clothing, the pads must be stretched tight to fit.The 2nd and last one i tried burned me enough to peel off my skin.I doubt the older, looser product would've burned me as easily.And it's not easy to let a burn near the waistline heal.Yes, i know to be careful, remove them if one feels they are too hot, not to sleep in them.I miss the old product.It didn't make me itch either." action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event burn me enough to peel off my skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events of itch and product size issue are non-serious and assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event burn me enough to peel off my skin as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The events of itch and product size issue are non-serious and assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Event verbatim [preferred term].Burned me enough to peel off my skin [thermal burn], burned me enough to peel off my skin [skin exfoliation], itch [pruritus], the pads must be stretched tight to fit [product size issue], , narrative: this is a spontaneous report from a contactable consumer or other non hcp.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (no lot number or expiration date provided) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On an unspecified date, the patient reported "the new pads are disappointing.Even though i am a woman who usually wears xs to small clothing, the pads must be stretched tight to fit.The 2nd and last one i tried burned me enough to peel off my skin.I doubt the older, looser product would've burned me as easily.And it's not easy to let a burn near the waistline heal.Yes, i know to be careful, remove them if one feels they are too hot, not to sleep in them.I miss the old product.It didn't make me itch either." action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Per the product quality group: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number 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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Rsnbly suggest device malfunc?: no; severity of harm: n/a; site sample status: not received.Follow-up (02apr2016): follow-up attempts are completed.No further information is expected.Follow-up (08jun2020): new information received received from a product complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.There was limited device specific information provided, no batch number 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 adverse event safety request for investigation.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 adverse event safety request for investigation.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.Rsnbly suggest device malfunc?: no; severity of harm: n/a; site sample status: not received.

• 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: 5477618
• MDR Text Key: 39649107
• Report Number: 1066015-2016-00037
• 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: 02/04/2016

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: 02/04/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: 02/04/2016
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention