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

Lot Number T65598

Device Problem Use of Device Problem (1670)

Patient Problems Swelling (2091); Rupture (2208)

Event Date 04/09/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] had blisters on her neck/some of the blisters have ruptured, so it is very tender and she would say a little bit worse.[blister rupture] , so she put one heatwrap on.She fell asleep [device use error] ,.Case narrative:this is a spontaneous report from a contactable other hcp (nurse) reported for herself.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number t65598, expiration date sep2020, upc number: (b)(4), from an unspecified date at an unspecified frequency for neck pain.Medical history included pacemaker syndrome but the patient would not say she has heart disease.The patient's concomitant medications were not reported.The patient was a registered nurse.She had really bad trouble with her neck, so she has used thermacare for years.She loved it, but her neck got really bad yesterday, so she put one heatwrap on.She fell asleep, but she always slept on her side and she woke up and had blisters on her neck on (b)(6) 2019.She used thermacare neck pain therapy.There were no breaks or anything in the heat wrap.She was asking what would have caused that.Some of the blisters have ruptured, so it was very tender and she would say a little bit worse.The event was medically significant.The patient was not taking any relevant medications, including topical medications, at the time of the adverse events.The blister was related to the heatwrap.The sample of the product was available to be returned.The action taken in response to the event was unknown.The outcome of the event "had blisters on her neck/some of the blisters have ruptured, so it is very tender and she would say a little bit worse" was not recovered, the outcome of the other event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "blister rupture" and "device use error" 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 "blister rupture" and "device use error" 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.

Event Description

Event verbatim [preferred term] had blisters on her neck/some of the blisters have ruptured, so it is very tender and she would say a little bit worse.[blister rupture] , so she put one heatwrap on.She fell asleep [device use error] ,.Case narrative:this is a spontaneous report from a contactable other hcp (nurse) reported for herself.A 68-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number t65598, expiration date sep2020, upc number: (b)(4), from an unspecified date at an unspecified frequency for neck pain.Medical history included pacemaker syndrome but the patient would not say she has heart disease.The patient's concomitant medications were not reported.The patient was a registered nurse.She had really bad trouble with her neck, so she has used thermacare for years.She loved it, but her neck got really bad yesterday, so she put one heatwrap on.She fell asleep, but she always slept on her side and she woke up and had blisters on her neck on 09apr2019.She used thermacare neck pain therapy.There were no breaks or anything in the heat wrap.She was asking what would have caused that.Some of the blisters have ruptured, so it was very tender and she would say a little bit worse.The event was medically significant.The patient was not taking any relevant medications, including topical medications, at the time of the adverse events.The blister was related to the heatwrap.The sample of the product was available to be returned.The action taken in response to the event was unknown.The outcome of the event "had blisters on her neck/some of the blisters have ruptured, so it is very tender and she would say a little bit worse" was not recovered, the outcome of the other event was unknown.According to product quality complaint group: thermacare neck pain therapy batch t65598 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 11jan2019 for a related complaint.An evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 c - 41.6 c) per spec-25353, effective: 04aug2017.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).The return sample does not support the complaint for wrap causes blisters.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports an adverse event of blisters.The cause of the adverse event is 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 (08may2019): new information received from product quality complaints group included: investigation results.Company clinical evaluation comment based on the information provided, the events of "blister rupture" and "device use error" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "blister rupture" and "device use error" 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action 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: 8524690
• MDR Text Key: 142329515
• Report Number: 1066015-2019-00111
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733015025
• UDI-Public: 305733015025
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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: Health Professional
• Device Expiration Date: 09/01/2020
• Device Lot Number: T65598
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 54