MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE FUER FLEXIBLE ANWENDUNG; DISPOSABLE PACK, HOT

Lot Number AX0572E; 4483610

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/24/2021

Event Type  Injury  

Event Description

Burn blister [burns second degree].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare fuer flexible anwendung) lot number ax0572e, via an unspecified route of administration from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced burn blister on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome 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, "burn blisters".The cause of the consumer stating the wrap caused "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid burn blisters.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 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 [burns second degree]: , narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare fuer flexible anwendung) lot number ax0572e, via an unspecified route of administration from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced burn blister on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to the product quality complaint group: 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, "burn blisters".The cause of the consumer stating the wrap caused "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid burn blisters.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 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 ((b)(6) 2021): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.

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, "burn blisters".The cause of the consumer stating the wrap caused "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid burn blisters.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 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 [burns second degree], did not control the skin condition.The patient knew the content of the product use leaflet [intentional device misuse], , narrative: this is a spontaneous report from a contactable consumer.A 55-year-old non-pregnant female patient started to receive thermacare heatwrap (thermacare fuer flexible anwendung) (device lot number 1: ax0572e; device lot number 2: 4483610, expiry date mar2022) from (b)(6) 2021 to (b)(6) 2021 at 1 heatwrap daily for 6-8 hours for back pain.The patient's medical history included an unspecified heart disorder from an unspecified date and unknown if ongoing.Concomitant medications were reported as none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no problems in the past.The patient began using suspect thermacare heatwraps daily from (b)(6) 2021 with no problems.On (b)(6) 2021, the patient applied the heatwrap to the lower back and the patient noticed burning after approximately 15 minutes.She stated she waited a bit, and after 25 minutes she removed the heatwrap as the pain increased.At approximately 14:00, the patient experienced a burn blister.The patient was not hospitalized as a result of the event.The patient's skin color is (very) light, but the skin is not sensitive and displays no disorders.The patient previously used a hot water bottle was used in 2020 for 1-2 days without any problems.The suspect product was applied directly onto skin with light trousers on it.The patient was not doing any sports while wearing the heat wrap.The patient did not control the skin condition.The patient knew the content of the product use leaflet.No medicines have been taken in the time when the condition occurred.Action taken in response to the event for thermacare heatwrap was continued.No therapeutic measures were taken as a result of the event.Clinical outcome of the event burn blister was not resolved with "encrustation" reported.Clinical outcome of the remaining event was unknown.According to the product quality complaint group: 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, "burn blisters".The cause of the consumer stating the wrap caused "burn blisters" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid burn blisters.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 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 (05feb2021): new information received from the product quality complaint group includes investigational results.Follow-up (09mar2021): new information received from the contactable consumer via angelini included: patient details, medical history, past product history, no concomitant medication, suspect product start/stop dates, suspect product indication, additional suspect product lot number and expiration date, action taken with suspect product, reaction data (additional event of intentional device misuse), event onset date, no hospitalization required and no therapeutic measures taken.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE FUER FLEXIBLE ANWENDUNG
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11285716
• MDR Text Key: 240309989
• Report Number: 1066015-2021-00016
• 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
• Report Date: 01/25/2021

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: 03/01/2022
• Device Lot Number: AX0572E; 4483610
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2021; 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80