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

Lot Number H43479

Device Problems Difficult to Remove (1528); Human-Device Interface Problem (2949)

Patient Problems Scarring (2061); Skin Tears (2516); Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

Company clinical evaluation comment: based on the information provided, the events thermal burn with skin exfoliation, and device misuse as described in this case represent 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 considered as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Burn( thermal burn) t-shirt was stuck to his back in places and skin came off with it (skin exfoliation) left the heatwrap on all night, may have dozed off now and again (device misuse).Scars.Case description: this is a spontaneous report from a contactable consumer or other non hcp who reported on behalf of her brother.A male patient of an unspecified age and ethnicity started to receive thermacare heatwrap (robax lower back and hip heat wrap) (device lot number: h43479, expiration date: august 2016) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated her brother used the heatwrap after hurting his back and having quite a bit of pain.She mentioned he read all the instructions and warnings prior to using the heatwrap.He placed the heatwrap over his t-shirt and left it on all night.He may have dozed off now and again, but did not feel the need to remove the wrap.When the patient removed the heatwrap in the morning, his t-shirt was stuck to his back in places and skin came off with it.Action taken with suspect product was unknown.Therapeutic measures included laser treatments, unspecified burn ointment and bandages for weeks.It was reported the burn healed quite a bit and the scars were fading.Clinical outcome of the events was resolving.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product in process specifications.Consumer alleges burn from wrap.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 irritations.The product effect may vary with each individual.The product complaint is not confirmed, not process related and not design related.

Event Description

Case description: this is a spontaneous report from a contactable consumer who reported on behalf of her brother.A male patient of an unspecified age and ethnicity started to receive thermacare heatwrap (robax lower back & hip heatwrap) (device lot number: h43479, expiration date: aug2016) from an unspecified date for back pain.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated her brother used the heatwrap after hurting his back and having quite a bit of pain.She mentioned he read all the instructions and warnings prior to using the heatwrap.He placed the heatwrap over his t-shirt and left it on all night.He may have dozed off now and again, but did not feel the need to remove the wrap.When the patient removed the heatwrap in the morning, his t-shirt was stuck to his back in places and skin came off with it.Action taken with suspect product was unknown.Therapeutic measures included laser treatments, unspecified burn ointment and bandages for weeks.It was reported the burn healed quite a bit and the scars were fading.Clinical outcome of the events was resolving.As of 17sep2015, the product quality complaint (pqc) group investigation results stated that the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product in process specifications.Consumer alleges burn from wrap.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 irritations.The product effect may vary with each individual.The product complaint is not confirmed, not process related and not design related.Additional information has been requested and will be provided as it becomes available.Follow-up (17sep2015): new information reported from the pqc group includes: product investigation summary results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events thermal burn with skin exfoliation, and device misuse as described in this case represent 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 considered as associated with the device use.This case meets final10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn with skin exfoliation, and device misuse as described in this case represent 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 considered as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Continued: evaluation summary the plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon review of batch device history records, in process quality check results or inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product in process specifications.Consumer alleges burn from wrap.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 irritations.The product effect may vary with each individual.The product complaint is not confirmed, not process related and not design related.

• Brand Name: ROBAX LOWER BACK AND HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017 ; 2127335544
• MDR Report Key: 4992215
• MDR Text Key: 22717986
• Report Number: 1066015-2015-00098
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Report Date: 07/31/2015

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: 08/01/2016
• Device Lot Number: H43479
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• 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