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

Lot Number DK2625

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Burn, Thermal (2530); Blister (4537); Skin Burning Sensation (4540)

Event Date 01/12/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term], itching burn sensation/blister/assuming it was like a burn blister/itching started to tingle [burns second degree], blister opened up [blister rupture], thought the wrap may be it was defective [device defective].Narrative: this is a spontaneous report from a contactable consumer.This (b)(6) year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number dk2625, expiration date feb2023, udi number (b)(6), at one wrap applied to the back of her lower neck from (b)(6) 2021 for sore, neck pain and felt stiff.Medical history and concomitant medications were none.Consumer reported for 3 count of thermacare neck, shoulder & wrist wraps.She wore one and everything was great.A few days she put on another one for three hours and it was itching and left blisters on her neck.She was assuming it was like a burn blister, occurred today ((b)(6) 2021), stated that only one blister opened up and she thought she scratched it while trying to take off wrap.It was tender around it.She used soap and water to clean it and placed a band-aid on it.It was an itching burn sensation, not stinging burn sensation, it was about the same.She first ever used the product on sunday when she purchased it.She used one wrap and it helped.She felt stiff today and she put on a wrap on her neck and it felt great, then it felt like it was itching and the itching started to tingle so she took the wrap off and saw the blister.Her sisters swears by the product and recommended the product to her.The patient was not pregnant.She was not post-menopausal.She was not currently under the care of a physician for any medical condition.She classified her skin tone as darker brown.She did not have sensitive skin, she had normal skin.She did not have abnormal skin conditions.Her skin can keloid if she got a cut.There was one wrap remaining.She used one on sunday and then one today.She used 3 hours on (b)(6) 2021.She used thermacare for about 5 hours on (b)(6) 2021.She did not have the same problem during previous use.She have not previously used other heat products for pain relief.She wore a normal t-shirt over it, attached the adhesive to body (neck).She did not engage in exercise while using the product.She was at her desk while working from home.She felt the sensation and it was itchy and adjusted herself, and moved shoulder around, when it continued she got up and tried to remove the wrap since her neck was sore.Wrap was removed and discontinued use.She cleaned the area and put a bandage on it, thought the wrap may be it was defective.She read the usage instructions on thermacare before used the product.She was not taking any medications during the time the problem was experienced.She did not consult a healthcare professional for the problem.The product was available to be sent to pfizer for evaluation.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2021.The outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Batch dk2625 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 the wrap caused " was itching and left blisters on her neck".The cause of the consumer stating the wrap was itching and left blisters on her neck is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event serious unknown for (nsw) 8hr products, refer to the 36-month attached trend chart for adverse event (nsw) 8hr 12jan2018 to 12jan2021.Site sample status was not received.Process related was no.Final confirmation status was not confirmed.

Event Description

Event verbatim [preferred term] itching burn sensation/blister/assuming it was like a burn blister/itching started to tingle [burns second degree], blister opened up [blister rupture], thought the wrap may be it was defective [device defective].Narrative: this is a spontaneous report from a contactable consumer.This 31-year-old female consumer started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number dk2625, expiration date feb2023, udi number (b)(4), at one wrap applied to the back of her lower neck from (b)(6) 2021 for sore, neck pain and felt stiff.Medical history and concomitant medications were none.Consumer reported for 3 count of thermacare neck, shoulder & wrist wraps.She wore one and everything was great.A few days she put on another one for three hours and it was itching and left blisters on her neck.She was assuming it was like a burn blister, occurred today ((b)(6) 2021), stated that only one blister opened up and she thought she scratched it while trying to take off wrap.It was tender around it.She used soap and water to clean it and placed a band-aid on it.It was an itching burn sensation, not stinging burn sensation, it was about the same.She first ever used the product on sunday when she purchased it.She used one wrap and it helped.She felt stiff today and she put on a wrap on her neck and it felt great, then it felt like it was itching and the itching started to tingle so she took the wrap off and saw the blister.Her sisters swears by the product and recommended the product to her.The patient was not pregnant.She was not post-menopausal.She was not currently under the care of a physician for any medical condition.She classified her skin tone as darker brown.She did not have sensitive skin, she had normal skin.She did not have abnormal skin conditions.Her skin can keloid if she got a cut.There was one wrap remaining.She used one on sunday and then one today.She used 3 hours on (b)(6) 2021.She used thermacare for about 5 hours on (b)(6) 2021.She did not have the same problem during previous use.She have not previously used other heat products for pain relief.She wore a normal t-shirt over it, attached the adhesive to body (neck).She did not engage in exercise while using the product.She was at her desk while working from home.She felt the sensation and it was itchy and adjusted herself, and moved shoulder around, when it continued she got up and tried to remove the wrap since her neck was sore.Wrap was removed and discontinued use.She cleaned the area and put a bandage on it, thought the wrap may be it was defective.She read the usage instructions on thermacare before used the product.She was not taking any medications during the time the problem was experienced.She did not consult a healthcare professional for the problem.The product was available to be sent to pfizer for evaluation.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2021.The outcome of the events was not resolved.According to product quality complaint group: batch dk2625 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 the wrap caused " was itching and left blisters on her neck".The cause of the consumer stating the wrap was itching and left blisters on her neck is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assmt.& rationale: an evaluation of the complaint confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (name) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event serious unknown for (nsw) 8hr products, refer to the 36-month trend chart for adverse event (nsw) 8hr (b)(6) 2018 to (b)(6) 2021.Site sample status was not received.Process related was no.Final confirmation status was not confirmed.Follow-up (22jan2021): follow-up attempts completed.No further information expected.Follow-up (21jan2021): 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: 11204460
• MDR Text Key: 230743581
• Report Number: 1066015-2021-00010
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 305733015025
• 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: 01/12/2021

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: 02/01/2023
• Device Lot Number: DK2625
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR