MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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

Patient Problems Hemorrhage/Bleeding (1888); Skin Erosion (2075); Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] the wrap pulled off the layer of skin that had already been burned by the disk on he wrap/the blister was oozing and bleeding onto her shirt/it had caused a blister [burns second degree] , the wrap pulled off the top layer of the dermis that was scalded [skin exfoliation] , the blister was oozing and bleeding onto her shirt/it was bleeding [wound haemorrhage].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at an unspecified dose for pain in her shoulder.The patient medical history was not reported.The patient's concomitant medications were not reported.She used a neck and shoulder heat wrap about 2 weeks ago ((b)(6) 2017).When she pulled off the wrap off, the wrap pulled off the top layer of the dermis that was scalded.The wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding.She reported that it had caused a blister.The blister was oozing and bleeding onto her shirt.She declined any treatment.She wanted to go to the doctor so she would know the degree of her burn, but as a teacher she did not have time to go.Regarding the outcome it reported it was tender back there and she was trying not to lean against anything.She reported the wraps were very comfortable to wear and the wrap stayed where you put it.She had a friend took pictures of her back.Reported it was undeniable because of the pattern of welts on her back.She was not sure if there was a warning if it could burn elderly people.She did not have the box.She discarded the boxes.She had the wrap and the wrapper at home.She reported the website says the product may result in burning if used on people 55 and older.This is the first time she heard of anything like that.She reported that she purchased the box a year ago and the recent wrap that she used was the last pad she had.She only used them when she had pretty dire pain.She has been using thermacare heat wraps off and on for years.The action taken in response to the events for thermacare heatwrap was unknown.The 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 events of "the wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding, it had caused a blister and the blister was oozing and bleeding onto her shirt" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "the wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding, it had caused a blister and the blister was oozing and bleeding onto her shirt" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 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 safety request for investigation.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.The sample had not been received by the site.

Event Description

Event verbatim [preferred term] , the wrap pulled off the layer of skin that had already been burned by the disk on he wrap/the blister was oozing and bleeding onto her shirt/it had caused a blister [burns second degree], the wrap pulled off the top layer of the dermis that was scalded [skin exfoliation], the blister was oozing and bleeding onto her shirt/it was bleeding [wound haemorrhage], narrative: this is a spontaneous report from a contactable consumer.A 64-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at an unspecified dose for pain in her shoulder.The patient medical history was not reported.The patient's concomitant medications were not reported.She used a neck and shoulder heat wrap about 2 weeks ago ((b)(6) 2017).When she pulled off the wrap off, the wrap pulled off the top layer of the dermis that was scalded.The wrap pulled off the layer of skin that had already been burned by the disk on the wrap and it was bleeding.She reported that it had caused a blister.The blister was oozing and bleeding onto her shirt.She declined any treatment.She wanted to go to the doctor so she would know the degree of her burn, but as a teacher she did not have time to go.Regarding the outcome it reported it was tender back there and she was trying not to lean against anything.She reported the wraps were very comfortable to wear and the wrap stayed wear you put it.She had a friend took pictures of her back.Reported it was undeniable because of the pattern of welts on her back.She was not sure if there was a warning if it could burn elderly people.She did not have the box.She discarded the boxes.She had the wrap and the wrapper at home.She reported the website says the product may result in burning if used on people 55 and older.This is the first time she heard of anything like that.She reported that she purchased the box a year ago and the recent wrap that she used was the last pad she had.She only used them when she had pretty dire pain.She has been using thermacare heat wraps off and on for years.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 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 safety request for investigation.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.The sample had not been received by the site.Follow-up (21feb2019): follow-up attempts are completed.No further information is expected.Follow-up (17feb2020): follow-up attempts are completed.No further information is expected.Follow-up (02jun2020): new information received from a product complaint group included: investigation results.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6998865
• MDR Text Key: 90969110
• Report Number: 1066015-2017-00155
• 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
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 47