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

Lot Number 424912

Device Problem Nonstandard Device (1420)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Type  Injury  

Event Description

Event verbatim [preferred term] created a sore [skin lesion] , when i put it on my neck and i took it off at night and it was blood on the thermacare [skin haemorrhage] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6) male consumer started to receive thermacare heatwrap (thermacare heatwrap) lot number 424912, expiration date jan2021, from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer stated, "i got notice that there was a recall on thermacare and i had purchased on (b)(6) and i have had it.I used it twice and it created a sore, actually blood.When i put it on my neck and i took it off at night and it was blood on the thermacare and i've done it twice." when probed for product details, consumer stated, "there is a number on here (b)(4)." the action taken in response to the events of the product was unknown.The outcome of the events 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 skin lesion and skin haemorrhage 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 skin lesion and skin haemorrhage 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

Created a sore [skin lesion], when i put it on my neck and i took it off at night and it was blood on the thermacare [skin haemorrhage].Case narrative: this is a spontaneous report from a contactable consumer.This 93-year-old male consumer started to receive thermacare heat wrap (thermacare neck, shoulder & wrist) lot number unknown expiration date jan2021, from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer stated, 'i got notice that there was a recall on thermacare and i had purchased on (b)(6) and i have had it.I used it twice and it created a sore, actually blood.When i put it on my neck and i took it off at night and it was blood on the thermacare and i've done it twice'.When probed for product details, consumer stated, 'there is a number on here b0028a96do.' the action taken in response to the events of the product was unknown.The outcome of the events was unknown.As of on (b)(6) 2019, the product quality complaint (pqc) group investigation summary: the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.Based on the pcom search for the subclass of adverse event safety request for investigation for (agency name) 8 hour products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety.Request for investigation for (agency name) 8 hour products.Additional information has been requested and will be provided as it becomes available.Follow-up (27jan2019): new information received from the product quality complaint group included: investigational results for thermacare neck/shoulder/wrist heat wrap 8 hr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of skin lesion and skin haemorrhage 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 skin lesion and skin haemorrhage 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.

Manufacturer Narrative

Investigation summary the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.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.Based on the pcom search for the subclass of adverse event safety request for investigation for (agency name) 8 hour products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety.Request for investigation for (agency name) 8 hour products.

• 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: 8133210
• MDR Text Key: 129442581
• Report Number: 1066015-2018-00178
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 01/01/2021
• Device Lot Number: 424912
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR