MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

She has a blister from a thermacare product [blister].Case narrative:this is a spontaneous report from a contactable consumer reporting for a patient.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The reporter stated "i received a voicemail from a patient on (b)(6) at 8:12 a.M.Stating that she has a blister from a thermacare product.That is all of the information that she provided regarding the event".The action taken in response to the event was unknown.The outcome of the event was unknown.Follow-up (26mar2019): follow-up attempts are completed.No further information is expected.Follow-up (29nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event of "blister" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event of "blister" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9260900
• MDR Text Key: 184468873
• Report Number: 1066015-2019-00271
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• 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