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

Lot Number S91704

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Event Description

Allergic reactions (redness /burn) [thermal burn], allergic reactions (redness /burn) [erythema], allergic reactions (redness /burn) [hypersensitivity].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age, started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number s91704, expiration date jun2020, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The pharmacist report that they received 2 thermacare heatwraps back: the female patient had allergic reactions (reddening/burn) from the third heatwrap onwards.According to the pharmacy employee, the redness looked more like an allergy.The action taken with thermacare heatwrap and the outcome of the event was not reported.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "allergic reactions (reddening/burn)" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Comment: based on the information provided, the events of "allergic reactions (reddening/burn)" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.

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 wrap caused "reddening/burn." the cause of the consumer stating the wrap caused reddening/burn 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 when using the device, 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

Allergic reactions (redness /burn) [thermal burn] , allergic reactions (redness /burn) [erythema] , allergic reactions (redness /burn) [hypersensitivity].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age, started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number s91704, expiration date jun2020, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The pharmacist report that they received 2 thermacare heatwraps back: the female patient had allergic reactions (reddening/burn) from the third heatwrap onwards.According to the pharmacy employee, the redness looked more like an allergy.Action taken with thermacare heatwrap and the outcome of the event was not reported.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 wrap caused "reddening/burn." the cause of the consumer stating the wrap caused reddening/burn 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 when using the device, 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 (19dec2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment based on the information provided, the events of "allergic reactions (reddening/burn)" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Comment: based on the information provided, the events of "allergic reactions (reddening/burn)" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.

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 wrap caused "reddening/burn." the cause of the consumer stating the wrap caused reddening/burn 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 when using the device, 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.Batch s91704 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 sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed with a date scope between 12/11/2016 through 12/11/2019 at the manufacturing site for complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown.The citi customizable search returned a total of 12 complaints for neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.There was no reasonable suggestion of device malfunction.The sample status at the site was not received.

Event Description

Event verbatim [preferred term] allergic reactions (redness /burn) [thermal burn], allergic reactions (redness /burn) [erythema], allergic reactions (redness /burn) [hypersensitivity], narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unspecified age, started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number s91704, expiration date jun2020, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The pharmacist report that they received 2 thermacare heatwraps back: the female patient had allergic reactions (reddening/burn) from the third heatwrap onwards.According to the pharmacy employee, the redness looked more like an allergy.Action taken with thermacare heatwrap and the outcome of the event was not reported.Additional information received from product quality complaint (pqc) group on 19dec2019 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 wrap caused "reddening/burn." the cause of the consumer stating the wrap caused reddening/burn 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 when using the device, 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.Additionally, product quality complaints reported the following investigation information on 08oct2020: batch s91704 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 sub class adverse event/serious/unknown received at the manufacturing site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed with a date scope between 12/11/2016 through 12/11/2019 at the manufacturing site for complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown.The citi customizable search returned a total of 12 complaints for neck/shoulder/wrist (nsw) 12hr products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.There was no reasonable suggestion of device malfunction.The sample status at the site was not received.Follow-up (19dec2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (29jan2020): follow-up attempts completed.No further information expected.Follow-up (08oct2020): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts completed.No further information expected., comment: based on the information provided, the events of "allergic reactions (reddening/burn)" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.

• 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: 9474473
• MDR Text Key: 187905742
• Report Number: 1066015-2019-00542
• 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: 12/02/2019

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: 06/01/2020
• Device Lot Number: S91704
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention