MAUDE Adverse Event Report: PFIZER CONSUMER HEALTHCARE (CANADA) ROBAX LOWER BACK & HIP HEATWRAP; DISPOSABLE PACK, HOT

Lot Number DF2013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/29/2021

Event Type  Injury  

Event Description

Burns all across my back [thermal burn]., narrative: this is a spontaneous report received from a contactable consumer (patient).A female patient of unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot number df2013, expiration date oct2022, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.The patient had been a satisfied customer for a few years now.In the years the patient had used the product never had an issue, even tell friends what a great product you have! on friday(b)(6) 2021.The patient used one of heat wraps and for the first time ever had the worst experience with your product.The patient put the heat wrap on in the morning and used it for the day at work (what the patient had always done)and didn't even notice until had gotten out of the shower that day that the wrap had left burns all across back.The patient used the product the same as always had, followed the instructions and it was used for 8 hours.The patient didn't understand how this could have happened, whether there was a faulty batch, or anything.The patient had attached some photos of burns and the package and wrap dug from the garbage.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] burns all across my back [thermal burn], , narrative: this is a spontaneous report received from a contactable consumer (patient).A female patient of unspecified age started to receive thermacare heatwrap (robax lower back & hip heatwrap) lot number df2013, expiration date oct2022, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.The patient had been a satisfied customer for a few years now.In the years the patient had used the product never had an issue, even tell friends what a great product you have! on friday (b)(6) 2021 the patient used one of heat wraps and for the first time ever had the worst experience with your product.The patient put the heat wrap on in the morning and used it for the day at work (what the patient had always done)and didn't even notice until had gotten out of the shower that day that the wrap had left burns all across back.The patient used the product the same as always had, followed the instructions and it was used for 8 hours.The patient didn't understand how this could have happened, whether there was a faulty batch, or anything.The patient had attached some photos of burns and the package and wrap dug from the garbage.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.According to product quality complaint group, the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "the wrap had left burns all across my back".The cause of the consumer stating "the wrap had left burns all across my back" is inconclusive since review of records does 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 irritations.The plant has reviewed this batch from a manufacturing 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 is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (08mar2021): new information received from product quality complaint group included: investigation results.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "the wrap had left burns all across my back".The cause of the consumer stating "the wrap had left burns all across my back" is inconclusive since review of records does 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 irritations.The plant has reviewed this batch from a manufacturing 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 is within expiration date.The product quality for the batch is not impacted by this complaint.

• Brand Name: ROBAX LOWER BACK & HIP HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTHCARE (CANADA); (a division of pfizer canada u; lc) 450-55 standish court; mississauga L5R4B 2; CA L5R4B2
• MDR Report Key: 11302047
• MDR Text Key: 230990022
• Report Number: 1066015-2021-00020
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Lot Number: DF2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention