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

Lot Number AX0572C

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

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Patient experienced burns [thermal burn], narrative: this is a spontaneous report from a non-contactable consumer.A patient of unspecified age and gender used thermacare heatwrap (thermacare fuer flexible anwendung), device lot number ax0572c, expiration date 31mar2022, on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burns on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term] patient experienced burns [thermal burn], , narrative: this is a spontaneous report from a contactable consumer.A male patient of unspecified age used thermacare heatwrap (thermacare fuer flexible anwendung), device lot number ax0572c, expiration date 31mar2022, on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced burns on an unspecified date and requiring ongoing treatment with sterile stripes and furacin ointment.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (25may2020): new information received from the same contactable consumer includes: patient gender, event treatment information and updated outcome.

Event Description

Event verbatim [preferred term]: patient experienced burns [thermal burn], the heat wraps got too hot [device issue].Narrative: this is a spontaneous report from a contactable consumer.A male patient of unspecified age used thermacare heatwrap (thermacare fuer flexible anwendung), device lot number ax0572c, expiration date 31mar2022, on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The heat wraps got too hot and the patient experienced burns on an unspecified date, requiring ongoing treatment with sterile stripes and furacin ointment.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was resolving.Product quality complaints provided the following investigation results: there was reasonable suggestion of device malfunction.Severity of harm was s3.The root cause category is non-assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot".The cause of the consumer stating the wrap became too hot is inconclusive since the review of records does not provide evidence to support defective products.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 is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (25may2020): new information received from the same contactable consumer includes: patient gender, event treatment information and updated outcome.Follow-up (19may2020): new information from product quality complaints includes investigation results.Additionally, this follow-up is being submitted to amend previously reported information: events (added "heat wraps got too hot") and narrative description.No follow-up attempts needed.No further information expected.

Manufacturer Narrative

There was reasonable suggestion of device malfunction.Severity of harm was s3.The root cause category is non-assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot".The cause of the consumer stating the wrap became too hot is inconclusive since the review of records does not provide evidence to support defective products.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 is within expiration date.The product quality for the batch is not impacted by this complaint.

Manufacturer Narrative

There was reasonable suggestion of device malfunction.Severity of harm was s3.The root cause category is non-assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot".The cause of the consumer stating the wrap became too hot is inconclusive since the review of records does not provide evidence to support defective products.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 is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] patient experienced burns [thermal burn], the heat wraps got too hot [device issue], narrative: this case is invalid due to being duplicate to 2020189910.This is a spontaneous report from a contactable consumer.A male patient of unspecified age used thermacare heatwrap (thermacare fuer flexible anwendung), device lot number ax0572c, expiration date 31mar2022, on an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The heat wraps got too hot and the patient experienced burns on an unspecified date, requiring ongoing treatment with sterile stripes and furacin ointment.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was resolving.Product quality complaints provided the following investigation results: there was reasonable suggestion of device malfunction.Severity of harm was s3.The root cause category is non-assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap "got too hot".The cause of the consumer stating the wrap became too hot is inconclusive since the review of records does not provide evidence to support defective products.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 is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (b)(6) 2020): new information received from the same contactable consumer includes: patient gender, event treatment information and updated outcome.Follow-up (b)(6) 2020): new information from product quality complaints includes investigation results.Additionally, this follow-up is being submitted to amend previously reported information: events (added "heat wraps got too hot") and narrative description.No follow-up attempts needed.No further information expected.Follow-up (b)(6) 2020): this case is being deleted from the database for the following reason: duplicate case.This follow-up report is to notify that the case 2020189910 and case 2020191559 are duplicates.All subsequent follow-up information will be reported under manufacturer report number 2020189910.

• 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: 10074827
• MDR Text Key: 191673868
• Report Number: 1066015-2020-00120
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Lot Number: AX0572C
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention