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

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

Patient Problems Skin Irritation (2076); Skin Tears (2516)

Event Date 01/01/2018

Event Type  Injury  

Event Description

The heatwrap took the skin off with it [skin exfoliation], narrative: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) year-old female patient started to use thermacare heatwrap (robax lower back & hip heatwrap) from an unspecified date for pulled back.Medical history included osteoporosis from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.On an unspecified date in 2018 (reported as 2 years ago), the patient lifted furniture with her husband and pulled her back.Because of her pulled back, she used back heatwraps, the bigger ones.She stated she applied the product to her lower back and when she went to remove the heatwrap it took the skin off with it.It was like round circles of skin were gone off of her back where the black things on the heatwrap were.She does not know if it is charcoal or what in the heatwrap black things.She recovered completely from this event.The heatwrap was discarded.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included putting unspecified salve on the affected area.Clinical outcome of the event was resolved on an unspecified date.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] the heatwrap took the skin off with it [skin exfoliation], , narrative: this is a spontaneous report from a contactable consumer.A 68-year-old female patient started to use thermacare heatwrap (robax lower back & hip heatwrap) from an unspecified date for pulled back.Medical history included osteoporosis from an unknown date.The patient's concomitant medications were not reported.On an unspecified date in 2018 (reported as 2 years ago), the patient lifted furniture with her husband and pulled her back.Because of her pulled back, she used back heatwraps, the bigger ones.She stated she applied the product to her lower back and when she went to remove the heatwrap it took the skin off with it.It was like round circles of skin were gone off of her back where the black things on the heatwrap were.She does not know if it is charcoal or what in the heatwrap black things.She recovered completely from this event.The heatwrap was discarded.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included putting unspecified salve on the affected area.Clinical outcome of the event was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results for complaint subclass: adverse event/serious/unknown: summary of investigation: the investigation was conducted for an unknown lot number lower back/ hip (lbh) 8 hour product.Process related?: no.Final confirmation status: not confirmed.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 events / serious / unknown.The manufacturing operations employ quality control procedures, which include in process testing, thermal testing and visual inspection to ensure the quality of the packaged product.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Site sample status : not received.Follow-up ((b)(6) 2020): follow-up attempts completed.No further information is expected.Follow-up ((b)(6) 2020): new information received from product quality complaint group included: investigation results.Follow-up attempts not required.No further information is expected.

Manufacturer Narrative

Summary of investigation: the investigation was conducted for an unknown lot number lower back/ hip (lbh) 8 hour product.Process related?: no.Final confirmation status: not confirmed.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 events / serious / unknown.The manufacturing operations employ quality control procedures, which include in process testing, thermal testing and visual inspection to ensure the quality of the packaged product.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Exped trend actions taken: based on this citi search, there is no trend identified for the subclass of adverse event/serious/unknown.Site sample status : not received.

• 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 i; nc.) 450-55 standish court; mississauga L5R4B 2; CA L5R4B2
• MDR Report Key: 10755159
• MDR Text Key: 213690890
• Report Number: 1066015-2020-00180
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR