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

Lot Number R44759

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414); Partial thickness (Second Degree) Burn (2694)

Event Date 06/06/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] skin reaction associated with pain.The skin was red with blisters/ burn [burns second degree].Case narrative:this is a spontaneous report received from a contactable pharmacist via (b)(6), the (b)(6) regulatory authority.Regulatory authority report number (b)(4).A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number r44759 11/12, from an unspecified date to an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.It was reported after 3 days of use, the patient presented on the patch pause area, a skin reaction associated with pain on (b)(6) 2017.The skin was red with vesicles.The doctor established that it was a burn and prescribed ialugen plus cream.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.It was reported the device was not available for evaluation.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges painful skin reaction (burn) from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term] skin reaction associated with pain.The skin was red with blisters/ burn [burns second degree].Case narrative: this is a spontaneous report received from (b)(6), the (b)(6) regulatory authority.The regulatory authority report number is vk_20170713_06.A contactable pharmacist reported a (b)(6) year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: r44759, expiration date: oct 2019) from an unspecified date at an unspecified frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.It was reported after 3 days of use, the patient presented on the patch pause area, a skin reaction associated with pain on (b)(6) 2017.The skin was red with vesicles.The doctor established that it was a burn and prescribed ialugen plus cream.Action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.It was reported the device was not available for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges painful skin reaction (burn) from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (28jul2017): new information received from product quality complaints (pqc) group included: product quality investigation results.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges painful skin reaction (burn) from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Event verbatim [preferred term].Skin reaction associated with pain.The skin was red with blisters/ burn/burn was situated below the cervicals at the level of the trapezius and of the size of the patch/marks remain [burns second degree].Case narrative: this is a spontaneous report received from (b)(4), the swiss regulatory authority.The regulatory authority report number is (b)(4).A contactable pharmacist reported that a (b)(6) year-old female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number: r44759, expiration date: oct 2019) cutaneously from (b)(6) 2017 to (b)(6) 2017 once a day for torticollis.Relevant medical history and concomitant medications were none.It was reported that the patient did not have diabetes, rheumatoid arthritis, heart disease, poor circulation, neuropathy or decreased sensation, pregnancy, skin allergies, rashes or other skin disorder, memory or cognitive concerns, or other relevant medical conditions.She was not taking any relevant medications, including topical medications, at the time of the event.The patient presented on the patch pause area, a skin reaction associated with pain on (b)(6) 2017.The skin was red with vesicles (blisters).The doctor established that it was a burn and prescribed ialugen plus cream (used since 2 months) and disinfection at the office.No surgical intervention such as debridement was required.This was a "new" event.Burn was situated below the cervicals at the level of the trapezius and of the size of the patch.Marks remain.The action taken with thermacare heatwrap was permanently withdrawn.The event resolved with sequelae in 2017.The pharmacist assessed that there was a causal relationship between thermacare and the event.It was reported the device was not available for evaluation.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges painful skin reaction (burn) from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow up (28jul2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (08aug2017): new information reported from the contactable pharmacist includes: patient data (weight, height, not pregnant), medical history (none), concomitant medications (none), suspect product data (route of administration, start date, stop date, frequency, action taken), and event data (updated onset date, outcome, stop date, causality; additional event description of "burn was situated below the cervicals at the level of the trapezius and of the size of the patch/marks remain"; additional treatment details).Follow-up attempts are completed.No further information is expected.

• 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: 6748623
• MDR Text Key: 81243671
• Report Number: 1066015-2017-00127
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Lot Number: R44759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/03/2017; 08/14/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR