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

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only 1 of the 6 stayed on his neck.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events "have to find some adhesive tape to get the wraps to stay for just a little while" and "recently he had 2 that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.

• 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 Key: 6185237
• MDR Text Key: 62712493
• Report Number: 1066015-2016-00166
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• 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 Date: 05/01/2019
• Device Lot Number: R23464
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2017; 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 Number: 1
• Treatment: ALENDRONATE SODIUM; ATORVASTATIN; LISINOPRIL; XELJANZ
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR