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

Lot Number CM3242

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 02/16/2021

Event Type  Injury  

Event Description

Burn blister on her neck [burns second degree], narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from (b)(6) (manufacturer control number (b)(4)), license party for thermacare heatwrap.A female patient of an unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist), lot number cm3242, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.On an unknown date, the patient experienced burn blister on her neck after using the patch (burns second degree).The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Information on the lot/batch number has been requested.

Event Description

Event verbatim [preferred term].Burn blister on her neck [burns second degree], , narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from angelini pharma (manufacturer control number de1087), license party for thermacare heatwrap.A female patient of an unknown age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number cm3242, expiration date aug2022), on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not reported.On an unknown date, the patient experienced burn blister on her neck after using the patch (burns second degree).Action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information received from product quality complaint (pqc) group included investigation results.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 a "a burn blister on her neck after using the patch".The cause of the consumer stating the wrap caused a "a burn blister on her neck after using the patch" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 (25feb2021): new information received from product quality complaints (pqc) group included: suspect product expiration date and product quality investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

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 a "a burn blister on her neck after using the patch".The cause of the consumer stating the wrap caused a "a burn blister on her neck after using the patch" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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.

Manufacturer Narrative

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 a "a burn blister on her neck after using the patch".The cause of the consumer stating the wrap caused a "a burn blister on her neck after using the patch" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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] burn blister on her neck [burns second degree], one part had been getting very hot [device issue], , narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from (b)(6) (manufacturer control number de1087), license party for thermacare heatwrap.A female patient of an unknown age (under 60 years old) started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number cm3242, expiration date aug2022), on an unknown date for an unknown indication.Relevant medical history was not reported.Concomitant medication were none.On (b)(6) 2021, the patient experienced burn blister on her neck after using the patch (burns second degree).The patient herself had applied the wrap.After one part had been getting very hot, the wrap was removed and the burning was visible.The localization was neck.No surgical intervention was required, but treatment was required (medigel, pressure point still visible).The reporter assessed the event as non-serious.It was stated as unknown if the patient would experience scars or persisting damage.Action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.The reporter assessed the event causality as related to thermacare.Additional information received from product quality complaint (pqc) group included investigation results.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 a "a burn blister on her neck after using the patch".The cause of the consumer stating the wrap caused a "a burn blister on her neck after using the patch" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 (25feb2021): new information received from product quality complaints (pqc) group included: suspect product expiration date and product quality investigation results.Follow-up (02mar2021): new information from the contactable pharmacist includes: patient information (age details, height and weight), concomitant medications (none), additional event detaills, new event (one part had been getting very hot), treatment information, reporter's seriousness assessment (non-serious) and causality assessment (related).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: 11401480
• MDR Text Key: 240613046
• Report Number: 1066015-2021-00027
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Lot Number: CM3242
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70