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

Lot Number N15778

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Scarring (2061); Swelling (2091)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Allergic reaction right in the area where it was used [application site hypersensitivity], itching with reddening at application site [application site pruritus], itching with reddening at application site [application site erythema], formation of pimples, which opened with blood [acne], formation of pimples, which opened with blood [wound haemorrhage], inflammation of pimples [dermatitis], they were getting scarred now [scar].Case narrative:this is a spontaneous report from a contactable pharmacist.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: n15778 04/21, expiration date: mar2019) from 2015 for an unspecified indication.Relevant medical history was not reported.Concomitant medication included ibuprofen, methocarbamol (robax).The pharmacist reported that the patient had always used the same product and now she had an allergic reaction right in the area where it was used.Later, the pharmacist reported that after application of thermacare the patient developed itching on the application site, with reddening and formation of pimples.Pimples opened with blood.Inflammation of pimples.They were getting scarred now.Events lasted (b)(6) 2016- (b)(6) 2017.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events of formation of pimples and inflammation of pimples was resolved with sequel in (b)(6) 2017.The outcome of other events was resolved in (b)(6) 2017.Additional information has been requested and will be provided as it becomes available.Follow-up (12jan2017): new information received from the contactable pharmacist includes: patient age, thermacare heatwrap start date, concomitant medication, added new events itching on the application site, with reddening and formation of pimples, pimples opened with blood, inflammation of pimples, they were getting scarred now.No follow-up attempts are needed.No further information is expected.Follow-up (28dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event are medically assessed as associated with the use of the device, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out., comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event are medically assessed as associated with the use of the device, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.

Event Description

Allergic reaction right in the area where it was used [application site hypersensitivity], itching with reddening at application site [application site pruritus], itching with reddening at application site [application site erythema], formation of pimples, which opened with blood [acne], formation of pimples, which opened with blood [wound haemorrhage], inflammation of pimples [dermatitis] , they were getting scarred now [scar].Case narrative: this is a spontaneous report from a contactable pharmacist.A 50-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: n15778 04/21, expiration date: mar2019) from 2015 for an unspecified indication.Relevant medical history was not reported.Concomitant medication included ibuprofen, methocarbamol (robax).The pharmacist reported that the patient had always used the same product and now she had an allergic reaction right in the area where it was used.Later, the pharmacist reported that after application of thermacare the patient developed itching on the application site, with reddening and formation of pimples.Pimples opened with blood.Inflammation of pimples.They were getting scarred now.Events lasted (b)(6) 2016- (b)(6) 2017.After consultation with the patient, there were no burns but an allergic reaction to the glue.Patient was not treated by a physician.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events of formation of pimples and inflammation of pimples was resolved with sequel in (b)(6) 2017.The outcome of other events was resolved in (b)(6) 2017.Additional information has been requested and will be provided as it becomes available.Follow-up (12jan2017): new information received from the contactable pharmacist includes: patient age, thermacare heatwrap start date, concomitant medication, added new events itching on the application site, with reddening and formation of pimples, pimples opened with blood, inflammation of pimples, they were getting scarred now.No follow-up attempts are needed.No further information is expected.Follow-up (28dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (07nov2019): new information from contactable pharmacist included: event details.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event are medically assessed as associated with the use of the device, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.Comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event are medically assessed as associated with the use of the device, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.

Event Description

Event verbatim [preferred term] allergic reaction right in the area where it was used [application site hypersensitivity] , itching with reddening at application site [application site pruritus] , itching with reddening at application site [application site erythema] , formation of pimples, which opened with blood [acne] , formation of pimples, which opened with blood [wound haemorrhage] , inflammation of pimples [dermatitis] , they were getting scarred now [scar].Case narrative:this is a spontaneous report from a contactable pharmacist.A 50-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: n15778 04/21, expiration date: mar2019) from 2015 for an unspecified indication.Relevant medical history was not reported.Concomitant medication included ibuprofen, methocarbamol (robax).The pharmacist reported that the patient had always used the same product and now she had an allergic reaction right in the area where it was used.Later, the pharmacist reported that after application of thermacare the patient developed itching on the application site, with reddening and formation of pimples.Pimples opened with blood.Inflammation of pimples.They were getting scarred now.Events lasted (b)(6)2016- (b)(6)2017.After consultation with the patient, there were no burns but an allergic reaction to the glue.Patient was not treated by a physician.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events of formation of pimples and inflammation of pimples was resolved with sequel in (b)(6)2017.The outcome of other events was resolved in (b)(6)2017.Additional information has been requested and will be provided as it becomes available.Follow-up (12jan2017): new information received from the contactable pharmacist includes: patient age, thermacare heatwrap start date, concomitant medication, added new events itching on the application site, with reddening and formation of pimples, pimples opened with blood, inflammation of pimples, they were getting scarred now.No follow-up attempts are needed.No further information is expected.Follow-up (28dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (07nov2019): new information from contactable pharmacist included: event details.Follow-up attempts are completed.No further information is expected.Follow-up (15jan2020): 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 events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" 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, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out., comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" 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, as it was determined that a causal relationship between the suspect device and the events 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 after use of thermacare wraps, she "developed itching on the application site, with reddening and formation of pimples." the cause of the consumer developing itching with reddening and formation of pimples 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].Allergic reaction right in the area where it was used [application site hypersensitivity] , itching with reddening at application site [application site pruritus] , itching with reddening at application site [application site erythema] , formation of pimples, which opened with blood [acne] , formation of pimples, which opened with blood [wound haemorrhage] , inflammation of pimples [dermatitis] , they were getting scarred now [scar].Case narrative:this is a spontaneous report from a contactable pharmacist.A 50-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) (lot number: n15778, expiration date: mar2019) from 2015 for an unspecified indication.Relevant medical history was not reported.Concomitant medication included ibuprofen, methocarbamol (robax).The pharmacist reported that the patient had always used the same product and now she had an allergic reaction right in the area where it was used.Later, the pharmacist reported that after application of thermacare the patient developed itching on the application site, with reddening and formation of pimples.Pimples opened with blood.Inflammation of pimples.They were getting scarred now.Events lasted (b)(6) 2016- (b)(6) 2017.After consultation with the patient, there were no burns but an allergic reaction to the glue.Patient was not treated by a physician.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events of formation of pimples and inflammation of pimples was resolved with sequel in (b)(6) 2017.The outcome of other events was resolved in (b)(6) 2017.Product quality complaints provided the following investigation 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 after use of thermacare wraps, she "developed itching on the application site, with reddening and formation of pimples." the cause of the consumer developing itching with reddening and formation of pimples 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 (12jan2017): new information received from the contactable pharmacist includes: patient age, thermacare heatwrap start date, concomitant medication, added new events itching on the application site, with reddening and formation of pimples, pimples opened with blood, inflammation of pimples, they were getting scarred now.No follow-up attempts are needed.No further information is expected.Follow-up (28dec2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (07nov2019): new information from contactable pharmacist included: event details.Follow-up attempts are completed.No further information is expected.Follow-up (15jan2020): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (17jan2020): new information received from product quality complaints includes: updated lot number and investigation conclusion.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the events "allergic reaction right in the area where it was used, itching on the application site, with reddening and formation of pimples; pimples opened with blood; inflammation of pimples, and getting scarred" 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, as it was determined that a causal relationship between the suspect device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.The product quality for the batch is not impacted by this complaint.There is not a complaint trend for any class(es) associated to the suggested key product complaints database terms.No further investigations or actions is 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: 9257507
• MDR Text Key: 180966121
• Report Number: 1066015-2019-00288
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2019
• Device Lot Number: N15778
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROBAX; ROBAX; ROBAX; ROBAX
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR