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

Lot Number X25951

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Rash (2033); Urticaria (2278)

Event Type  Injury  

Event Description

Red spots [rash macular], small crusts [scab], pruritus [pruritus].Case narrative: this is a spontaneous case received from contactable pharmacist via reception desk and pfizer customer care.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap) (device lot number x25951, expiration date oct-2021) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.The pharmacist reported that after the application of only two patches, the patient experienced red spots, with the formation of small crusts and pruritus without feeling of warmth or burn.This effect occurred not after the application of the first patch, but of the second one, before the end of the 8 hours of application.The customer was informed about the risk of burns due to compression of patch at the time of purchase, therefore the application was carried out correctly by the patient.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.In waiting for more information from the customer, the pharmacist requested whether a refund of the packaging was possible for the customer, who cannot no longer use the remaining patches.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

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 she had "red spots on her skin, itching and felt warmth sensation." the cause of the consumer stating the wrap caused red spots on her skin, itching and felt warmth sensation 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] red spots [rash macular] , small crusts [scab] , pruritus [pruritus] ,.Case narrative:this is a spontaneous report received from contactable pharmacist via reception desk and pfizer customer care.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number x25951, expiration date 31oct2021, from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown.The pharmacist reported that after the application of only two patches, the patient experienced red spots, with the formation of small crusts and pruritus without feeling of warmth or burn.This effect occurred not after the application of the first patch, but of the second one, before the end of the 8 hours of application.The customer was informed about the risk of burns due to compression of patch at the time of purchase, therefore the application was carried out correctly by the patient.Action taken with the thermacare therapy in response to the events and the outcome of the events were unknown at the time of this report.In waiting for more information from the customer, the pharmacist requested whether a refund of the packaging was possible for the customer, who cannot no longer use the remaining patches.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.According to the product quality complaint group on 20mar2020: 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 she had "red spots on her skin, itching and felt warmth sensation." the cause of the consumer stating the wrap caused red spots on her skin, itching and felt warmth sensation 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 (14feb2020): new follow-up information received from product complaint group includes trade name of thermacare heatwrap and exact expiration date.Follow-up (20mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed as a quality defect).There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.

Event Description

Event verbatim [preferred term] red spots [rash macular] , small crusts [scab] , pruritus [pruritus] ,.Case narrative:this is a spontaneous case received from contactable pharmacist via reception desk and pfizer customer care.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number x25951, expiration date 31oct2021) from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown at the time of this report.The pharmacist reported that after the application of only two patches, the patient experienced red spots, with the formation of small crusts and pruritus without feeling of warmth or burn.This effect occurred not after the application of the first patch, but of the second one, before the end of the 8 hours of application.The customer was informed about the risk of burns due to compression of patch at the time of purchase, therefore the application was carried out correctly by the patient.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.In waiting for more information from the customer, the pharmacist requested whether a refund of the packaging was possible for the customer, who cannot no longer use the remaining patches.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (14feb2020): new follow-up information received from product complaint group includes trade name of thermacare heatwrap and exact expiration date.Company clinical evaluation comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Site sample status: not received.Summary of investigation: batch x25951 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.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 she had "red spots on her skin, itching and felt warmth sensation." the cause of the consumer stating the wrap caused red spots on her skin, itching and felt warmth sensation 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Lot trend action taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown for neck/shoulder/wrist pain therapy heat wrap products.Refer to the 36 month trend chart attachment nsw 8 hr adverse event serious unknown (b)(6) 2018 to (b)(6) 2020.Exped trend actions taken: there was deviation from (b)(4), complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).

Event Description

Event verbatim [preferred term].Red spots [rash macular].Small crusts [scab].Pruritus [pruritus].Narrative: this is a spontaneous report received from contactable pharmacist via reception desk and pfizer customer care.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) device lot number x25951, expiration date 31oct2021, from an unspecified date for an unspecified indication.Relevant medical history and the relevant concomitant medications were unknown.The pharmacist reported that after the application of only two patches, the patient experienced red spots, with the formation of small crusts and pruritus without feeling of warmth or burn.This effect occurred not after the application of the first patch, but of the second one, before the end of the 8 hours of application.The customer was informed about the risk of burns due to compression of patch at the time of purchase, therefore the application was carried out correctly by the patient.Action taken with the thermacare therapy in response to the events and the outcome of the events were unknown at the time of this report.In waiting for more information from the customer, the pharmacist requested whether a refund of the packaging was possible for the customer, who cannot no longer use the remaining patches.According to product quality complaint: reasonably suggest device malfunction was yes and severity of harm was s3.According to the product quality complaint group on 20mar2020: site sample status: not received.Summary of investigation: batch x25951 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.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 she had "red spots on her skin, itching and felt warmth sensation." the cause of the consumer stating the wrap caused red spots on her skin, itching and felt warmth sensation 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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown 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.Lot trend action taken: a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this customizable citi search, a trend does not exist for the subclass adverse event/serious/unknown for neck/shoulder/wrist pain therapy heat wrap products.Refer to the 36 month trend chart attachment nsw 8 hr adverse event serious unknown (b)(6) 2018 to (b)(6) 2020.Exped trend actions taken: there was deviation from (b)(4), complaint trending guidelines, effective (b)(6) 2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in (b)(4), action item (b)(4).Follow-up (14feb2020): new follow-up information received from product complaint group includes trade name of thermacare heatwrap and exact expiration date.Follow-up (20mar2020): new information received from product quality complaint group includes investigation results.Follow-up (16oct2020): new information received from product quality complaint group includes updated trend information.No follow up attempt needed.No further information expected., comment: based on the information provided, the events "red spots, with the formation of small crusts and pruritus" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.The root cause category is non-assignable (complaint not confirmed as a quality defect).There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions are suggested at this time.

• 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: 9714670
• MDR Text Key: 185943230
• Report Number: 1066015-2020-00041
• 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,Followup
• Report Date: 02/04/2020

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: 10/31/2021
• Device Lot Number: X25951
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/28/2020; 04/15/2020; 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention