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 Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

A burn blister from the heatwrap that she used, it was blistered and it hurt [burns second degree].Looks like it was getting infected [blister infected].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 receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she got a burn blister from the heatwrap that she used.She stated she doubted a second degree burn on her back.The second day after she had used the heatwrap, it looked like it was getting infected, it was blistered and it hurt.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 events burn blister and infected blister 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.This case meets initial 10-day (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events burn blister and infected blister 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.This case meets initial 10-day (b)(6) and 30-day fda reportability.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term].A burn blister from the heatwrap that she used, it was blistered and it hurt [burns second degree], looks like it was getting infected [blister infected], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she got a burn blister from the heatwrap that she used.She stated she doubted a second degree burn on her back.The second day after she had used the heatwrap, it looked like it was getting infected, it was blistered and it hurt.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up (19may2016): follow-up attempts are completed.No further information is expected.Follow-up (19jun2020): new information received from a product quality complaints included: investigation results.

• 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: 5510640
• MDR Text Key: 40782052
• Report Number: 1066015-2016-00051
• 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: 03/07/2016

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: 03/07/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: 03/07/2016
• 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