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

Lot Number M61532

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/16/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] burnt her skin; burned area is still bubbled up like a blister [burns second degree], sleeping while wearing the product, used 2 two heatwraps, did not check skin under the wrap [intentional device misuse], because they were so little she had to use 2 heatwraps; they didn't go across her shoulders.[device issue], case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) years old black female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m61532, expiration date oct2018, from (b)(6) 2016 to (b)(6) 2016 for one day for 3 to 4 hours, at an unknown frequency for inflammation in her shoulder.Medical history included pulmonary embolism from 2012 to 2012, pain from an unknown date and unknown if ongoing and post menopausal.Concomitant medication included tizanidine (tizanidine) 4 mg, 3x/day, which isn't helping to relieve her pain.Past product history included thermacare heatwrap (thermacare heatwrap) and did not experience the same problem.The patient said that she went to the urgent care on (b)(6) 2016 because she was having an issue with her shoulder and the physician told her to alternate ice and heat and so she purchased the thermacare neck, wrist and shoulders heatwraps because the ice she was using wasn't helping her pain.The patient experienced it burnt her skin; burned area is still bubbled up like a blister, woke up with the blister on (b)(6) 2016 with outcome of not recovered.The patient said that she only wore the thermacare neck, wrist and shoulders heatwrap for about 3-4 hours on friday evening (b)(6) 2016.She fell asleep because her arm was hurting, and woke up with the blister.She also reported because they were so little she had to use 2 heatwraps; they didn't go across her shoulder on (b)(6) 2016 with outcome of recovered.The patient said that she did not put the heatwraps directly on her skin.The patient said that she was wearing a tank top.There were no relevant diagnostic tests.Therapeutic measures taken as a result of burnt her skin; burned area is still bubbled up like a blister included neosporin so she does not get an infection.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.She was not currently under the care of a physician for any medical condition.She classified her skin tone as honey brown caramel.She does not have sensitive skin or any abnormal skin conditions.She does not have any remaining product.The patient previously used a heating pad and did not experience the same problem.She reported she was sleeping while wearing the product.She attached the adhesive to her clothing.She wore it for about 3 hours.She did not engage in exercise while wearing the product.She did not check under the skin while wearing the product.She read the instructions before using the product.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 second degree burn, intentional device misuse and device issue as described in this case are considered 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.This case meets initial 10-day eu and 30-day fda reportability., comment: based on the information provided, the events of second degree burn, intentional device misuse and device issue as described in this case are considered 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.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Batch m61532 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 wrap ¿burnt her skin¿ and she ¿woke up with a blister.¿ the cause of the consumer stating the wrap ¿burnt her skin¿ and she ¿woke up with a blister¿ is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 at the time this investigation was written has expired.The expiry date was oct2018.The product quality for the batch is not impacted by this complaint.Site sample status: not received; rsnbly suggest device malfunc?: no ; severity of harm: n/a.

Event Description

Event verbatim [preferred term] burnt her skin; burned area is still bubbled up like a blister [burns second degree], sleeping while wearing the product, used 2 two heatwraps, did not check skin under the wrap [intentional device misuse], because they were so little she had to use 2 heatwraps; they didn't go across her shoulders.[device issue].Narrative: this is a spontaneous report from a contactable consumer.A 50-years-old female patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m61532, expiration date oct2018, (b)(6) 2016 for one day for 3 to 4 hours, at an unknown frequency for inflammation in her shoulder.Medical history included pulmonary embolism from 2012 to 2012, pain from an unknown date and unknown if ongoing and post menopausal.Concomitant medication included tizanidine (tizanidine) 4 mg, 3x/day, which isn't helping to relieve her pain.Past product history included thermacare heatwrap (thermacare heatwrap) and did not experience the same problem.The patient said that she went to the urgent care on(b)(6) 2016 because she was having an issue with her shoulder and the physician told her to alternate ice and heat and so she purchased the thermacare neck, wrist and shoulders heatwraps because the ice she was using wasn't helping her pain.The patient experienced it burnt her skin; burned area is still bubbled up like a blister, woke up with the blister on (b)(6) 2016 with outcome of not recovered.The patient said that she only wore the thermacare neck, wrist and shoulders heatwrap for about 3-4 hours on friday evening (b)(6) 2016.She fell asleep because her arm was hurting, and woke up with the blister.She also reported because they were so little she had to use 2 heatwraps; they didn't go across her shoulder on (b)(6) 2016 with outcome of recovered.The patient said that she did not put the heatwraps directly on her skin.The patient said that she was wearing a tank top.There were no relevant diagnostic tests.Therapeutic measures taken as a result of burnt her skin; burned area is still bubbled up like a blister included neosporin so she does not get an infection.The action taken with thermacare heatwrap was permanently withdrawn on (b)(6) 2016.She was not currently under the care of a physician for any medical condition.She classified her skin tone as honey brown caramel.She does not have sensitive skin or any abnormal skin conditions.She does not have any remaining product.The patient previously used a heating pad and did not experience the same problem.She reported she was sleeping while wearing the product.She attached the adhesive to her clothing.She wore it for about 3 hours.She did not engage in exercise while wearing the product.She did not check under the skin while wearing the product.She read the instructions before using the product.Per product quality: batch m61532 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: 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 wrap "burnt her skin" and she "woke up with a blister." the cause of the consumer stating the wrap "burnt her skin" and she "woke up with a blister" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 at the time this investigation was written has expired.The expiry date was oct2018.The product quality for the batch is not impacted by this complaint.Site sample status: not received; rsnbly suggest device malfunc?: no ; severity of harm: n/a.Follow-up (11nov2016): follow-up attempts are completed.No further information is expected.Follow-up (10aug2020): new information received from product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.

• 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: 5973679
• MDR Text Key: 55575798
• Report Number: 1066015-2016-00119
• 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: 09/19/2016

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: 10/01/2018
• Device Lot Number: M61532
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TIZANIDINE; TIZANIDINE [DOSAGE FORM:] TABLET; TIZANIDINE
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 79