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

Lot Number M59552

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Irritation (2076)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Applies a sports wrist band around it/wears it longer than 8 hrs/ wears it on a daily basis [intentional device misuse], skin irritation [skin irritation], slept in the product [device use error], used on her hand because she had tremors [device use issue].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m59552, expiration date sep 2018, via an unspecified route of administration from 2016 at an unspecified dose, used on her hand because she had tremors.The patient's medical history and concomitant medications were not reported.The patient started using the product a couple months ago.She used it on her hand because she had tremors.Once she applied the wrap she also applied a sports wrist band around it.This helped the hand when she applied the sport wrist band around it as well.She wore the product on a daily basis and wore longer than 8 hours.She experienced skin irritation, but it did still help her.She used cream on the skin irritation.She slept in the product as well.The product helped her fall asleep when she put it on before bedtime because of her tremors.She was just wondering what harm it was going to do by wearing it longer than the 8 hours.She gave her skin breaks from the product.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (23 nov 2016): follow-up attempts are completed.No further information is expected.Follow-up (28 oct 2019): this follow-up is being submitted to upgrade the case to a serious, reportable mdr.Company clinical evaluation comment: based on the available information, the events skin irritation and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events device use error and device use issue as described are non-serious.A causal relationship between the device and the event cannot be ruled out.Comment: based on the available information, the events skin irritation and intentional device misuse as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events device use error and device use issue as described are non-serious.A causal relationship between the device and the event cannot be ruled out.

Event Description

Event verbatim [preferred term] applies a sports wrist band around it/wears it longer than 8 hrs [intentional device misuse], skin irritation [skin irritation], slept in the product [device use error], used on her hand because she had tremors [device use issue], , narrative: this is a spontaneous report from a contactable consumer reported for herself.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m59552, expiration date sep2018, via an unspecified route of administration from 2016 at an unspecified dose, used on her hand because she had tremors.The patient's medical history and concomitant medications were not reported.The patient started using the product a couple months ago.She used it on her hand because she had tremors in 2016.Once she applied the wrap she also applied a sports wrist band around it in 2016.This helped the hand when she applied the sport wrist band around it as well.She wore the product on a daily basis and wore longer than 8 hours in 2016.She experienced skin irritation, but it did still help her in 2016.She used cream on the skin irritation.She slept in the product as well in 2016.The product helped her fall asleep when she put it on before bedtime because of her tremors.She was just wondering what harm it was going to do by wearing it longer than the 8 hours.She gave her skin breaks from the product.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality complaint group: the root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports skin irritation from wrap.The cause of the irritated skin is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Reasonbly suggest device malfunction was no.Site sample status was not received.Follow-up (b)(6) 2016): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2019): this follow-up is being submitted to upgrade the case to a serious, reportable mdr.Follow-up (b)(6) 2020): follow-up attempts are completed.No further information is expected.Follow-up (b)(6) 2020: new information received from a product quality complaint group includes product investigation results.No follow up attempts needed.No further information is expected.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports skin irritation from wrap.The cause of the irritated skin is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Reasonbly suggest device malfunction was no.Site sample status was not received.

• 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: 9387338
• MDR Text Key: 185223656
• Report Number: 1066015-2016-00126
• 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
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2018
• Device Lot Number: M59552
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention