MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091)

Event Date 04/28/2020

Event Type  Injury  

Event Description

Red circles on her knee that were not really blisters, where the circles in the wrap were located [rash macular], they looked like little circles where the circles were in the patch [device issue], narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), udi#: (b)(4), on (b)(6) 2020 at 1 wrap applied topically to the right knee for about 1 hour for her knee was bothering her.Medical history and concomitant medications were none.The patient stated that she was calling about thermacare heatwraps, she used one yesterday on (b)(6) 2020, she had it on her knee and took it off about an hour later and she got these spots that looked like little blisters.She was wondering why the product did this? the patient stated that she had 4 more of the wraps that had never been opened, she was a little scared to use them.She clarified that they were not really blisters, they looked like little circles where the circles were in the patch.She stated she had red circles on her knee that were not really blisters, where the circles in the wrap were located.She stated that she did touch one, she accidentally scratched it, so that one will probably form into a blister.She stated that there was that big one on her knee and then there were like 5 or 6 little ones on the side.She stated that they were not really blisters, they were red circles with a big one on the knee cap and smaller ones on the sides.The patient stated she put the wrap on her knee yesterday on (b)(6) 2020, about dinner time, and left it in place for about an hour.She noticed immediately upon removing the wrap, that the red spots were present.She stated that the spots looked a little, not as red as when she took the wrap off, but she touched them and they were a little painful, especially the one that she accidentally scratched.She stated that they were persisting.The patient provided the suspect product as: thermacare advanced muscle pain therapy, she stated it was the long wrap someone can use for lower back or knee.When queried to clarify if the product was the lower back and hip or the elbow and knee, she stated that it was just the advanced muscle pain therapy one.She provided a upc number off a different box of the same product that she purchased, but she no longer had the packaging for the affected product to provide udi number, lot number or expiry, as all the packaging had been thrown in the trash.The patient reported the wrap was placed on her right knee.She stated that she put some little itch cream on the red spots because that was all she had.The product was available to be sent for evaluation, the patient still had the wrap itself.There was no investigation assessment.The action taken in response to the events for the product was unknown.The outcome of the events was not recovered.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

This investigation was conducted for an unknown lot number muscle & joint product.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 and/or return sample 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/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 product being packaged.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.Site sample status was not received.

Event Description

Event verbatim [preferred term]: red circles on her knee that were not really blisters, where the circles in the wrap were located [rash macular].They looked like little circles where the circles were in the patch [device issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A 62-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain).Udi#: (b)(4).On (b)(6) 2020 at 1 wrap applied topically to the right knee for about 1 hour for her knee was bothering her.Medical history and concomitant medications were none.The patient stated that she was calling about thermacare heatwraps, she used one yesterday on (b)(6) 2020, she had it on her knee and took it off about an hour later and she got these spots that looked like little blisters.She was wondering why the product did this? the patient stated that she had 4 more of the wraps that had never been opened, she was a little scared to use them.She clarified that they were not really blisters, they looked like little circles where the circles were in the patch.She stated she had red circles on her knee that were not really blisters, where the circles in the wrap were located.She stated that she did touch one, she accidentally scratched it, so that one will probably form into a blister.She stated that there was that big one on her knee and then there were like 5 or 6 little ones on the side.She stated that they were not really blisters, they were red circles with a big one on the knee cap and smaller ones on the sides.The patient stated she put the wrap on her knee yesterday on (b)(6) 2020, about dinner time, and left it in place for about an hour.She noticed immediately upon removing the wrap, that the red spots were present.She stated that the spots looked a little, not as red as when she took the wrap off, but she touched them and they were a little painful, especially the one that she accidentally scratched.She stated that they were persisting.The patient provided the suspect product as: thermacare advanced muscle pain therapy, she stated it was the long wrap someone can use for lower back or knee.When queried to clarify if the product was the lower back and hip or the elbow and knee, she stated that it was just the advanced muscle pain therapy one.She provided a upc number off a different box of the same product that she purchased, but she no longer had the packaging for the affected product to provide udi number, lot number or expiry, as all the packaging had been thrown in the trash.The patient reported the wrap was placed on her right knee.She stated that she put some little itch cream on the red spots because that was all she had.The product was available to be sent for evaluation, the patient still had the wrap itself.The action taken in response to the events for the product was unknown.The outcome of the events was not recovered.According to the product quality complaint group: this investigation was conducted for an unknown lot number muscle & joint product.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 and/or return sample 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/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 product being packaged.Lot trend assmt.& rationale: a lot trend was not performed.The lot number is unknown.Site sample status was not received.Follow-up (19jun2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10031028
• MDR Text Key: 190340574
• Report Number: 1066015-2020-00110
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733013014
• UDI-Public: 305733013014
• 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: 04/29/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 95