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

Lot Number L31340

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Suffered major burns [thermal burn].Wore the wrap for 16 hours.[intentional device misuse].The picture is deceiving and it states 16 hours of relief on the box [product label confusion].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A male patient of an unspecified age and ethnicity started to receive thermacare heatwrap (robax lower back & hip heatwrap) (device lot number: l31340, expiration date: 31jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date in 2015, the patient reported he suffered major burns after wearing the heatwrap for 16 hours.He stated the picture is deceiving and it states 16 hours of relief on the box.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 of burns after wearing the heatwrap for 16 hours 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 of burns after wearing the heatwrap for 16 hours 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

The plant reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritation.

Event Description

Case description: this is a spontaneous report from a contactable consumer or other non hcp.A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (robax lower back & hip heatwrap) (device lot number: l31340, expiration date: 31jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date in 2015, the patient reported he suffered major burns after wearing the heatwrap for 16 hours.He stated the picture is deceiving and it states 16 hours of relief on the box.Action taken with the suspect product was unknown.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.The plant reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritation.Additional information has been requested and will be provided as it becomes available.Follow-up (15jan2016): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Company clinical evaluation comment: based on the information provided, the event of burns after wearing the heatwrap for 16 hours 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 final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event of burns after wearing the heatwrap for 16 hours 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 final 10-day eu and 30-day fda reportability.Continued: evaluation summary the plant reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product was within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleged burn from wrap.The cause of the alleged burn was inconclusive since review of records did not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritation.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5306771
• MDR Text Key: 33784801
• Report Number: 1066015-2015-00155
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

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
• Device Expiration Date: 01/31/2018
• Device Lot Number: L31340
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention