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

Lot Number W21702

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 09/17/2019

Event Type  Injury  

Event Description

Felt a skin reaction/massive skin irritation [skin irritation].Case narrative: this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started using thermacare heatwraps (thermacare joint & arthritis pain neck, shoulder & wrist) lot number w21702, expiration date nov2020, on (b)(6) 2019 for an unknown indication.Medical history included allergies against zinc oxide and rubber.Concomitant medications were none.Thermacare was used in the past and was well tolerated then.The pharmacist reported that the patient asked if an allergic reaction could be caused by the glue of thermacare heatwraps.She felt a skin reaction.She experienced massive skin irritation on (b)(6) 2019.Thermacare was stopped due to event on (b)(6) 2019 and the skin reaction disappeared.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The clinical outcome of the event was resolved on (b)(6) 2019.According to product quality complaint group: severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (23sep2019 and 14oct2019): new information received from product quality complaint group and the same contactable pharmacist included: severity of harm, patient data (weight, height), suspect product data (lot number, expiration date, start date, stop date, action taken, medical history, deny of concomitant medications, past product history, new event (massive skin irritation), event onset date, stop date and outcome, and case upgraded to serious malfunction reportable mdr.Company clinical evaluation comment: based on the information provided, the event skin irritation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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).Sample is not available for evaluation by the site; complaint cannot be confirmed.Consumer reports she "felt a skin reaction." the cause of the skin reaction is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive complaint not confirmed as a quality defect, since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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] felt a skin reaction/massive skin irritation [skin irritation] ,.Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started using thermacare heatwraps (thermacare joint & arthritis pain neck, shoulder & wrist) lot number w21702, expiration date nov2020, on (b)(6) 2019 for an unknown indication.Medical history included allergies against zinc oxide and rubber.Concomitant medications were none.Thermacare was used in the past and was well tolerated then.The pharmacist reported that the patient asked if an allergic reaction could be caused by the glue of thermacare heatwraps.She felt a skin reaction.She experienced massive skin irritation on (b)(6) 2019.Thermacare was stopped due to event on (b)(6) 2019 and the skin reaction disappeared.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The clinical outcome of the event was resolved on (b)(6) 2019.According to product quality complaint group: severity of harm: 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.Consumer reports she "felt a skin reaction." the cause of the skin reaction is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive complaint not confirmed as a quality defect, since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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 (23sep2019 and 14oct2019): new information received from product quality complaint group and the same contactable pharmacist included: severity of harm, patient data (weight, height), suspect product data (lot number, expiration date, start date, stop date, action taken, medical history, deny of concomitant medications, past product history, new event (massive skin irritation), event onset date, stop date and outcome, and case upgraded to serious malfunction reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (18dec2019): new information received from product quality complaint group includes investigation results company clinical evaluation comment: based on the information provided, the event skin irritation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event skin irritation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] felt a skin reaction/massive skin irritation [skin irritation].Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started using thermacare heatwraps (thermacare joint & arthritis pain neck, shoulder & wrist) lot number w21702, expiration date nov2020, on (b)(6) 2019 for an unknown indication.Medical history included allergies against zinc oxide and rubber.Concomitant medications were none.Thermacare was used in the past and was well tolerated then.The pharmacist reported that the patient asked if an allergic reaction could be caused by the glue of thermacare heatwraps.She felt a skin reaction.She experienced massive skin irritation on (b)(6) 2019.Thermacare was stopped due to event on (b)(6) 2019 and the skin reaction disappeared.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The clinical outcome of the event was resolved on (b)(6) 2019.According to product quality complaint group: severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (23sep2019 and 14oct2019): new information received from product quality complaint group and the same contactable pharmacist included: severity of harm, patient data (weight, height), suspect product data (lot number, expiration date, start date, stop date, action taken, medical history, deny of concomitant medications, past product history, new event (massive skin irritation), event onset date, stop date and outcome, and case upgraded to serious malfunction reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment: based on the information provided, the event skin irritation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] felt a skin reaction/massive skin irritation [skin irritation].Case narrative:this is a spontaneous report from a contactable pharmacist.A female patient of an unknown age started using thermacare heatwraps (thermacare joint & arthritis pain neck, shoulder & wrist) lot number w21702, expiration date nov2020, on (b)(6) 2019 for an unknown indication.Medical history included allergies against zinc oxide and rubber.Concomitant medications were none.Thermacare was used in the past and was well tolerated then.The pharmacist reported that the patient asked if an allergic reaction could be caused by the glue of thermacare heatwraps.She felt a skin reaction.She experienced massive skin irritation on (b)(6) 2019.Thermacare was stopped due to event on (b)(6) 2019 and the skin reaction disappeared.The action taken in response to the event of the product was permanently discontinued on (b)(6) 2019.The clinical outcome of the event was resolved on (b)(6) 2019.According to product quality complaint group: severity of harm: 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.Consumer reports she "felt a skin reaction.".The cause of the skin reaction is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive complaint not confirmed as a quality defect, since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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 (23sep2019 and 14oct2019): new information received from product quality complaint group and the same contactable pharmacist included: severity of harm, patient data (weight, height), suspect product data (lot number, expiration date, start date, stop date, action taken, medical history, deny of concomitant medications, past product history, new event (massive skin irritation), event onset date, stop date and outcome, and case upgraded to serious malfunction reportable mdr.Follow-up (19dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (18dec2019): new information received from product quality complaint group includes investigation results.Follow-up (24feb2020): this follow-up is being submitted to notify that the investigation is closed; no further results are expected., comment: based on the information provided, the event skin irritation as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

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.Consumer reports she "felt a skin reaction." the cause of the skin reaction is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive complaint not confirmed as a quality defect, since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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.

• Brand Name: THERMACARE JOINT & ARTHRITIS PAIN 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: 9444797
• MDR Text Key: 188585454
• Report Number: 1066015-2019-00537
• 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: 09/12/2019

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: 11/01/2020
• Device Lot Number: W21702
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2019; 12/31/2019; 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention