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

Lot Number W95403

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Pain (1994); Rash (2033)

Event Type  Injury  

Event Description

Got a bruise and it started to bleed [contusion], got a bruise and it started to bleed [haemorrhage], also got a rash [rash], adhesive was tight, it hurt when i pulled it off [pain], adhesive was tight, it hurt when i pulled it off [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number w95403, expiration date jun2027, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.Medical history included ongoing asthma, ongoing allergy.Concomitant medications included unspecified allergy tablets and asthma medication.The patient experienced bruises and rash from thermacare, 8 hours protection for the neck.She said the thermacare product was advanced heat therapy for muscle and joint pain.She had it for her neck and slept with it.Then when she was going to remove it, the adhesive was tight, it hurt when she pulled it off.She got a bruise and it started to bleed.She had also got a rash.The patient took daily allergy tablets and asthma medication.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

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 "bruising and rash from thermacare".The cause of the consumer stating the wrap bruised and left rash from thermacare 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.

Event Description

Event verbatim [preferred term] had it for her neck and slept with it.[device use error], got a bruise and it started to bleed/she still had marks after the tape.[contusion], got a bruise and it started to bleed [haemorrhage], also got a rash [rash], adhesive was tight, it hurt when i pulled it off [pain], adhesive was tight, it hurt when i pulled it off [device adhesion issue], the area is still swollen and itchy.[application site pruritus], the area is still swollen and itchy.[application site swelling], , narrative: this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number w95403, expiration date may2021, from an unspecified date for an unspecified indication.Medical history included ongoing asthma, ongoing allergy, urticaria one year ago (approx 2020) and ongoing skin problems.Concomitant medications included fexofenadine hydrochloride (telfast) 180 mg 4 times daily for allergy, asthma and urticaria.It was also reported that the patient took daily allergy tablets and asthma medication.The patient experienced bruises and rash from thermacare, 8 hours protection for the neck.She said the thermacare product was advanced heat therapy for muscle and joint pain.She had it for her neck and slept with it.Then when she was going to remove it, the adhesive was tight, it hurt when she pulled it off.She got a bruise and it started to bleed.She had also gotten a rash.The patient reported that 3 days after removing thermacare the area was still swollen and itchy.She still had marks after the tape.Action taken with thermacare was unknown.The outcome of the events of bruises, slept with it, adhesive was tight, it hurt when she pulled it off and got a bruise and it started to bleed was unknown, the remaining events was not resolved.According to product quality group: thermacare neck/shoulder/wrist, lot/batch: w95403, expiry date: may2021).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 "bruising and rash from thermacare".The cause of the consumer stating the wrap bruised and left rash from thermacare 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.Follow-up (21jan2021): additional information from the same contactable consumer includes new events and suspect drug data: (additional lot number reported as w9540306/27, expiry date 31may2021 product recoded as patient reported different product).Follow-up (27jan2021) new information from the same contactable consumer included: medical history added; concomitant medication updated and event information.Follow-up (09feb2021): new information received from product quality complaint group includes investigation results for lot number w95403.W9540306/27 was removed as it is not a valid lot number.

Event Description

Event verbatim [preferred term] got a bruise and it started to bleed [contusion], got a bruise and it started to bleed [haemorrhage], also got a rash [rash], adhesive was tight, it hurt when i pulled it off [pain], adhesive was tight, it hurt when i pulled it off [device adhesion issue], had it for her neck and slept with it.[device use error], the area is still swollen and itchy.[application site pruritus], the area is still swollen and itchy.[application site swelling], , narrative: this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number w95403, expiration date jun2027 and w9540306/27, expiry date may2021, from an unspecified date for an unspecified indication.Medical history included ongoing asthma and ongoing allergy.Concomitant medications included unspecified allergy tablets and asthma medication.The patient experienced bruises and rash from thermacare, 8 hours protection for the neck.She said the thermacare product was advanced heat therapy for muscle and joint pain.She had it for her neck and slept with it.Then when she was going to remove it, the adhesive was tight, it hurt when she pulled it off.She got a bruise and it started to bleed.She had also gotten a rash.The patient took daily allergy tablets and asthma medication.On (b)(6) 2021, the patient reported that 3 days after removing thermacare the area was still swollen and itchy.Action taken in response to the events of the product was unknown.The outcome of the events of bruises, slept with it, rash adhesive was tight, it hurt when she pulled it off and got a bruise and it started to bleed was unknown, the remaining events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (21jan2021): additional information from the same contactable consumer includes new events and suspect drug data: (additional lot number reported as w9540306/27, expiry date 31may2021 product recoded as patient reported different product).

Event Description

Event verbatim [preferred term] got a bruise and it started to bleed/she still had marks after the tape.[contusion].Got a bruise and it started to bleed [haemorrhage].Also got a rash [rash].Adhesive was tight, it hurt when i pulled it off [pain].Adhesive was tight, it hurt when i pulled it off [device adhesion issue].Had it for her neck and slept with it.[device use error.The area is still swollen and itchy.[application site pruritus].The area is still swollen and itchy.[application site swelling].Narrative: this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number=w95403, expiration date=jun2027 and w9540306/27, expiration date=may2021, from an unspecified date for an unspecified indication.Medical history included ongoing asthma, ongoing allergy, urticaria one year ago (approx 2020) and ongoing skin problems.Concomitant medications included fexofenadine hydrochloride (telfast) 180 mg 4 times daily for allergy, asthma and urticaria.The patient experienced bruises and rash from thermacare, 8 hours protection for the neck.She said the thermacare product was advanced heat therapy for muscle and joint pain.She had it for her neck and slept with it.Then when she was going to remove it, the adhesive was tight, it hurt when she pulled it off.She got a bruise and it started to bleed.She had also gotten a rash.The patient took daily allergy tablets and asthma medication.The patient reported that 3 days after removing thermacare the area was still swollen and itchy.She still had marks after the tape.Action taken with thermacare was unknown.The outcome of the events of bruises, slept with it, adhesive was tight, it hurt when she pulled it off and got a bruise and it started to bleed was unknown, the remaining events was not resolved.Follow-up (21jan2021): additional information from the same contactable consumer includes new events and suspect drug data: (additional lot number reported as w9540306/27, expiry date 31may2021 product recoded as patient reported different product).Follow-up (27jan2021) new information from the same contactable consumer included: medical history added; concomitant medication updated and event information.Additional information has been requested and will be provided as it becomes available.

• 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: 11245958
• MDR Text Key: 229296401
• Report Number: 1066015-2021-00015
• 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,Followup,Followup
• Report Date: 01/19/2021

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: 05/01/2021
• Device Lot Number: W95403
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2021; 02/09/2021; 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELFAST [DOSAGE FORM:]; TELFAST [DOSAGE FORM:]
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR