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

Model Number F00573303504

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Irritation (2076)

Event Type  Injury  

Event Description

Allergic reaction or sensitivity.[hypersensitivity], skin irritating is very itchy and red in the spot where the glue [skin irritation], skin irritating is very itchy and red in the spot where the glue [pruritus], skin irritating is very itchy and red in the spot where the glue [erythema], glues that stuck to the side of his neck was very irritating [device adhesion issue].Case narrative: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap) device lot number aw8655, expiration date mar2022, from an unspecified date for osteoarthritis in neck and pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The consumer reported that the glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity.It went away after a day or two after he wore it.He has osteoarthritis in his neck and these really helped him with pain.He bought like two boxes every couple a week so he bought a lot of these.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was resolved on an unspecified date.According to product quality complaint group: severity of harm was s3.Additional information has been requested and will be provided as it becomes available.Follow-up (23dec2019): this is a follow-up report from pfizer product quality group providing severity of harm, and case upgraded to a serious malfunction reportable mdr.Company clinical evaluation comment: based on the information provided, the events of "glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity" 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 of "glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity" 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

Batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record(dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "the skin irritating is very itchy and red in the spot where the glue." the cause of the wrap causing itching and a red spot is an 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

Event verbatim [preferred term] allergic reaction or sensitivity.[hypersensitivity] , skin irritating is very itchy and red in the spot where the glue [skin irritation] , skin irritating is very itchy and red in the spot where the glue [pruritus] , skin irritating is very itchy and red in the spot where the glue [erythema] , glues that stuck to the side of his neck was very irritating [device adhesion issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to receive thermacare heatwrap (robax neck & shoulder heatwrap) device lot number aw8655, expiration date mar2022, from an unspecified date for osteoarthritis in neck and pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The consumer reported that the glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity.It went away after a day or two after he wore it.He has osteoarthritis in his neck and these really helped him with pain.He bought like two boxes every couple a week so he bought a lot of these.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was resolved on an unspecified date.Product quality complaint group provided severity of harm of s3 and concluded: batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "the skin irritating is very itchy and red in the spot where the glue." the cause of the wrap causing itching and a red spot is an 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 (23dec2019): this is a follow-up report from pfizer product quality group providing severity of harm, and case upgraded to a serious malfunction reportable mdr.Follow-up (09jan2020): new information from product quality complaints includes: investigation conclusion.Based on the information provided, the events of "glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity" 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).No device malfunction has been identified.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., comment: based on the information provided, the events of "glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity" 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).No device malfunction has been identified.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.

Manufacturer Narrative

Batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record(dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "the skin irritating is very itchy and red in the spot where the glue." the cause of the wrap causing itching and a red spot is an 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

Event verbatim [preferred term] allergic reaction or sensitivity.[hypersensitivity] , skin irritating is very itchy and red in the spot where the glue [skin irritation] , skin irritating is very itchy and red in the spot where the glue [pruritus] , skin irritating is very itchy and red in the spot where the glue [erythema] , glues that stuck to the side of his neck was very irritating [device adhesion issue] , for osteoarthritis in neck plus back [intentional device use issue].Case narrative:this is a spontaneous report from a contactable consumer.A 61-year-old male patient started to receive thermacare heatwrap (robax neck & shoulder heatwrap) device lot number aw8655, expiration date mar2022, catalog #0 62107 33640 6, date of mfr 25apr2019, at one daily from an unspecified date for osteoarthritis in neck plus back and pain.The patient medical history was not reported.The patient's concomitant medications were none.The patient reported that the glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity.It went away after a day or two after he wore it.He has osteoarthritis in his neck and these really helped him with pain.He bought like two boxes every couple a week so he bought a lot of these.The patient had been using the single use neck + shoulder heat wraps and because he liked the product he wanted to inform that the adhesive currently used was irritating his skin to the point that he had to remove the heat wrap before it was finish doing its job.There was still lots of heat in the wrap but he was forced to remove the product because his skin becomes too itchy from the adhesive to continue to wear it.He liked the back wraps because they had velcroe strap, no adhesive.He didn't go to hospital or doctor just stopped using the product.Sad to say because really liked the delivery of heat to that area.He couldn't wear it with the adhesive as was.The product was stopped use due to adhesive irritation.The action taken in response to the events for thermacare heatwrap was permanently discontinued.The outcome of the events was resolved on an unspecified date.Product quality complaint group provided severity of harm of s3 and concluded: batch aw8655 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.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, "the skin irritating is very itchy and red in the spot where the glue." the cause of the wrap causing itching and a red spot is an 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 (23dec2019): this is a follow-up report from pfizer product quality group providing severity of harm, and case upgraded to a serious malfunction reportable mdr.Follow-up (09jan2020): new information from product quality complaints includes: investigation conclusion.Follow-up (15jan2020): new information received from the same contactable consumer included: patient data (age, weight, height), suspect product data (dosage, indication, action taken), deny of concomitant medication, new event (using it for osteoarthritis in neck plus back).Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of "glues that stuck to the side of his neck was very irritating.He thought we should change it to the velcro like with the back.The skin irritating was very itchy and red in the spot where the glue.Either he was having an allergic reaction or sensitivity" and "using it for osteoarthritis in neck plus back" 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).No device malfunction has been identified.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: ROBAX NECK & SHOULDER HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9561335
• MDR Text Key: 188823908
• Report Number: 1066015-2019-00566
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Model Number: F00573303504
• Device Catalogue Number: 0 62107 33640 6
• Device Lot Number: AW8655
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR