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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/01/2016

Event Type  Injury  

Event Description

Two big blisters in the shape of the heat cells on her back [blister].Case description: this is a spontaneous report from a contactable consumer reporting on behalf of her mother.This elderly female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (no lot number or expiration date was provided) from an unspecified date for arthritis and 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.The reporter stated her mother goes to adult daycare twice a week.On these days, she uses the heatwraps for her back pain.She has been using them for years and they really help with her arthritis.On an unspecified date in (b)(6) 2016, the reporter stated "we were really surprised this week to see two big blisters in the shape of the heat cells on her back.Unfortunately, she threw the box out so i don't have a lot number for your." 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.Company clinical evaluation comment based on the information provided, the event blisters 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.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event blisters 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.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

There was no reasonable suggestion of device malfunction.Sample status at the site was not received.A trend for the subclass of adverse event safety request for investigation with product type of lower back/hip (lbh) 8hr products was not identified.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 and/or 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 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.

Event Description

Event verbatim [preferred term] two big blisters in the shape of the heat cells on her back [blister].Case narrative:this is a spontaneous report from a contactable consumer reporting on behalf of her mother.This elderly female patient started to use thermacare heatwrap (thermacare lower back & hip) (no lot number or expiration date was provided) from an unspecified date for arthritis and 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.The reporter stated her mother goes to adult daycare twice a week.On these days, she uses the heatwraps for her back pain.She has been using them for years and they really help with her arthritis.On an unspecified date in (b)(6) 2016, the reporter stated "we were really surprised this week to see two big blisters in the shape of the heat cells on her back.Unfortunately, she threw the box out so i don't have a lot number for you." action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Product quality complaint provided the following information: there was no reasonable suggestion of device malfunction.Sample status at the site was not received.A trend for the subclass of adverse event safety request for investigation with product type of lower back/hip (lbh) 8hr products was not identified.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 and/or 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 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.Follow-up (18jun2016): follow-up attempts are completed.No further information is expected.Follow-up (19mar2020): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event blisters as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure and assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 5641235
• MDR Text Key: 44759142
• Report Number: 1066015-2016-00081
• 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: 04/21/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: 04/21/2016
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention