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

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

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Got burn first time [thermal burn].Scar on her back [scar].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) asian female patient started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for back pain.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 reported as seven years ago, the patient reported she got burn first time.She stated she "put on handkerchief it wasn't thick enough so she got burn and stopped using it".The patient mentioned the product hasn't improved from her last complaint.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures included burnol for her burn but it left a scar on her back.Clinical outcome of the event burn was resolved on an unspecified date.Clinical outcome of the event scar 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 events thermal burn as described in this case is 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 other event scar is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn as described in this case is 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 other event scar is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Investigations results from product quality complaints (pqc) group includes: 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 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.No lot-specific trend identified.Site sample status: not received.Reasonably suggest device malfunction: no.Severity of harm:.

Event Description

Event verbatim [preferred term], got burn first time [thermal burn], scar on her back [scar], , narrative: this is a spontaneous report from a contactable consumer or other non hcp.A 70-year-old female patient started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for back pain.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 reported as seven years ago, the patient reported she got burn first time.She stated she "put on handkerchief it wasn't thick enough so she got burn and stopped using it".The patient mentioned the product hasn't improved from her last complaint.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures included burnol for her burn but it left a scar on her back.Clinical outcome of the event burn was resolved on an unspecified date.Clinical outcome of the event scar was unknown.Investigations results from product quality complaints (pqc) group includes: 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 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.No lot-specific trend identified.Site sample status: not received.Reasonably suggest device malfunction: no.Severity of harm: n/a.Follow-up (09jul2016): follow-up attempts are completed.No further information is expected.Follow-up (01jun2020): new information received from a product quality complaints includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events thermal burn as described in this case is 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 other event scar is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

• 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: 5703350
• MDR Text Key: 46798931
• Report Number: 1066015-2016-00093
• 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: 05/13/2016

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: 05/13/2016
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR