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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Rupture (2208); Discharge (2225); Discomfort (2330); Blister (4537)

Event Type  Injury  

Event Description

Event verbatim [preferred term] i woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [blister rupture], i woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [skin injury], i woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [skin weeping], i let you imagine the pain and the discomfort.[discomfort], i let you imagine the pain and the discomfort.[pain], , narrative: this is a spontaneous report received from a contactable consumer from llp angelini (5066599), license party for thermacare heatwraps.A female patient of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient had used thermacare neck wraps a couple of weeks ago and after the applications (which took place in two different days ), she woke up in the morning with blisters which obviously did were broken secreting serum, to then have the epidermis visible, imagine the pain and the discomfort.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.

Event Description

Event verbatim [preferred term].I woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [blister rupture], i woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [skin injury], i woke up in the morning with blisters which obviously do they are broken by secreting serum, and then have the epidermis visible [skin weeping], i let you imagine the pain and the discomfort.[discomfort], i let you imagine the pain and the discomfort.[pain], , narrative: this case is invalid due to being a duplicate of aer# (b)(4).This is a spontaneous report received from a contactable consumer from llp angelini ((b)(4)), license party for thermacare heatwraps.A female patient of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient had used thermacare neck wraps a couple of weeks ago and after the applications (which took place in two different days ), she woke up in the morning with blisters which obviously were broken secreting serum, to then have the epidermis visible, imagine the pain and the discomfort.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.Follow-up (02mar2021): this is a follow-up report to notify that the cases (b)(4) are duplicates.All subsequent follow-up information will be reported under manufacturer report number 2021169487.This case is being deleted from the database for the following reason : duplicate case.

• 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: 11406196
• MDR Text Key: 244302771
• Report Number: 1066015-2021-00030
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention