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U.S. Department of Health and Human Services

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

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PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT Back to Search Results
Lot Number R23464
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Skin Irritation (2076); Injury (2348); Inadequate Pain Relief (2388)
Event Type  Injury  
Event Description
Skin blister , have to find some adhesive tape to get the wraps to stay for just a little while [device use error] , recently i had 2 that did not stick at all on my neck [device adhesion issue] , used thermacare neck, shoulder & wrist for degenerative disc disease and osteopenia [product use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.An (b)(6) male patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number r23464 06/27, expiration date may2019, via an unspecified route of administration from an unspecified date at 1 wrap per day for neck pain and rheumatoid arthritis (ra).The patient medical history included had 6 procedures on his neck, rheumatoid arthritis in all joints and degenerative disc disease and osteopenia.Concomitant medications included ongoing tofacitinib citrate (xeljanz) 5 mg daily, alendronate sodium 70 mg weekly, lisinopril 20 mg daily, and atorvastatin 40 mg daily.The consumer reported that when the stick, they were wonderful, but recently he had 2 that did not stick at all on his neck.The neck heat wraps had not enough adhesive to stay on his neck.It was very disappointing to spend the money, trying to neck pain relief then have to find some adhesive tape to get the wraps to stay for just a little while.The consumer further reported that only 1 of the 6 stuck on the other 5 had to be held in place around his neck with adhesive tape which caused skin blister.He had 6 procedures on his neck due to his ra which was the reason he used the heatwrap.He was just really upset that only 1 of the 6 stayed on his neck.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events "have to find some adhesive tape to get the wraps to stay for just a little while" and "recently he had 2 that did not stick at all on his neck" was resolved on an unspecified date.The outcome of skin blister was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (07dec2016): new information received from a contactable consumer includes: patient age, medial history, concomitant medications, suspect product lot number, expiration date, added new event skin blister, updated events outcome.Company clinical evaluation comment based on the information provided, the events blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use., comment: based on the information provided, the events blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use.
 
Manufacturer Narrative
The root cause category is non assignable (complaint not confirmed).The review of raw material records does not provide evidence to support defective product, nor has the alleged defective wrap been received at the site for evaluation.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.
 
Event Description
Event verbatim [preferred term] skin blister [blister] , have to find some adhesive tape to get the wraps to stay for just a little while [device use error] , recently i had 2 that did not stick at all on my neck [device adhesion issue] , used heatwrap for rheumatoid arthritis [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.An (b)(6) male patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: r23464, expiration date: may2019) from an unspecified date at 1 wrap per day for neck pain and rheumatoid arthritis (ra).The patient's medical history included had 6 procedures on his neck, rheumatoid arthritis in all joints and degenerative disc disease and osteopenia.Concomitant medications included ongoing tofacitinib citrate (xeljanz) 5 mg daily, alendronate sodium 70mg weekly, lisinopril 20 mg daily and atorvastatin 40 mg daily.On an unspecified date, the patient reported that when they stick, they were wonderful, but recently he had 2 that did not stick at all on his neck.The neck heatwraps did not have enough adhesive to stay on his neck.It was very disappointing to spend the money, trying for neck pain relief then have to find some adhesive tape to get the wraps to stay for just a little while.The patient further reported that only 1 of the 6 stuck and the other 5 had to be held in place around his neck with adhesive tape which caused skin blister.He had 6 procedures on his neck due to his ra which was the reason he used the heatwrap.He was just really upset that only 1 of the 6 stayed on his neck.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events "have to find some adhesive tape to get the wraps to stay for just a little while" and "recently he had 2 that did not stick at all on his neck" was resolved on an unspecified date.The outcome of skin blister was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The review of raw material records does not provide evidence to support defective product, nor has the alleged defective wrap been received at the site for evaluation.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information has been requested and will be provided as it becomes available.Follow-up (07dec2016): new information received from a contactable consumer includes: patient age, medial history, concomitant medications, suspect product lot number, expiration date, added new event skin blister, updated events outcome.Follow up (03jan2017): 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 blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use., comment: based on the information provided, the events blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use.
 
Manufacturer Narrative
The root cause category is non assignable (complaint not confirmed).The review of raw material records does not provide evidence to support defective product, nor has the alleged defective wrap been received at the site for evaluation.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.
 
Event Description
Skin blister, have to find some adhesive tape to get the wraps to stay for just a little while [device use error] , recently i had 2 that did not stick at all on my neck [device adhesion issue] , used heatwrap for rheumatoid arthritis [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.An (b)(6) male patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: r23464, expiration date: may2019) from an unspecified date at 1 wrap per day for neck pain and rheumatoid arthritis (ra).The patient's medical history included had 6 procedures on his neck, rheumatoid arthritis in all joints and degenerative disc disease and osteopenia.Concomitant medications included ongoing tofacitinib citrate (xeljanz) 5 mg daily, alendronate sodium 70 mg weekly, lisinopril 20 mg daily and atorvastatin 40 mg daily.On an unspecified date, the patient reported that when they stick, they were wonderful, but recently he had 2 that did not stick at all on his neck.The neck heatwraps did not have enough adhesive to stay on his neck.It was very disappointing to spend the money, trying for neck pain relief then have to find some adhesive tape to get the wraps to stay for just a little while.The patient further reported that only 1 of the 6 stuck and the other 5 had to be held in place around his neck with adhesive tape which caused skin blister.He had 6 procedures on his neck due to his ra which was the reason he used the heatwrap.He was just really upset that only 1 of the 6 stayed on his neck.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events "have to find some adhesive tape to get the wraps to stay for just a little while" and "recently he had 2 that did not stick at all on his neck" was resolved on an unspecified date.The outcome of skin blister was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).The review of raw material records does not provide evidence to support defective product, nor has the alleged defective wrap been received at the site for evaluation.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Additional information has been requested and will be provided as it becomes available.Follow-up (07dec2016): new information received from a contactable consumer includes: patient age, medial history, concomitant medications, suspect product lot number, expiration date, added new event skin blister, updated events outcome.Follow up (03jan2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (24jan2017): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use., comment: based on the information provided, the events blister and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The other events device adhesion issues and device use in unapproved indication are assessed as associated with device use.
 
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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
Manufacturer Contact
b green
235 e42nd street
new york, NY 10017
MDR Report Key6185237
MDR Text Key62712493
Report Number1066015-2016-00166
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 10/31/2016
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 Date05/01/2019
Device Lot NumberR23464
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/06/2017
01/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ALENDRONATE SODIUM; ATORVASTATIN; LISINOPRIL; XELJANZ
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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