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

Lot Number W24812

Device Problem Excessive Heating (4030)

Patient Problems Itching Sensation (1943); Pain (1994); Local Reaction (2035); Skin Irritation (2076)

Event Type  Injury  

Event Description

Strong itching and painful skin reddening at application site [application site pruritus], strong itching and painful skin reddening at application site [application site erythema], strong itching and painful skin reddening at application site [application site pain], remarkably hot patch [device issue], narrative: this is a spontaneous report from a contactable consumer based on information received by pfizer from angelini (at4661), license party for thermacare heatwrap.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare flexible use), device lot number w24812, via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient experienced strong itching and painful skin reddening at application site.The patient reported remarkably hot patch.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Batch w24812 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.An evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.A visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not exist for this batch.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 patch was remarkably hot".The cause of the wrap being " remarkably hot" is inconclusive since review of records does not provide evidence to support defective product.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] strong itching and painful skin reddening at application site [application site pruritus], strong itching and painful skin reddening at application site [application site erythema], strong itching and painful skin reddening at application site [application site pain], remarkably hot patch [device issue], , narrative: this is a spontaneous report from a contactable consumer based on information received by pfizer from angelini (at4661), license party for thermacare heatwrap.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare flexible use), device lot number w24812, expiry feb2021, via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient experienced strong itching and painful skin reddening at application site.The patient reported remarkably hot patch.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality complaints: there was no reasonable suggestion of device malfunction.A sample was not received a t the site.Batch w24812 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.An evaluation of the complaint history confirms that this is the first complaint for the subclass wrap/patch/pad too hot received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.A visual evaluation was performed to identify a potential trend for the subclass.On this basis, a trend does not exist for this batch.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 patch was remarkably hot".The cause of the wrap being " remarkably hot" is inconclusive since review of records does not provide evidence to support defective product.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 (07jan2021): follow up attempts completed.No further information expected.Followup (11jan2021): new information from product complaints group included: expiry and investigation results.

• Brand Name: THERMACARE FLEXIBLE USE
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 11118353
• MDR Text Key: 225160575
• Report Number: 1066015-2021-00005
• 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
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Lot Number: W24812
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention