MAUDE Adverse Event Report: PFIZER INC. THERMACARE HEATWRAPS; PACK, HOT OR COLD, DISPOSABLE

Lot Number EC7090

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

Patient Problems Erythema (1840); Discomfort (2330); Superficial (First Degree) Burn (2685); Swelling/ Edema (4577)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Narrative from staff: rn in to see patient with another rn at shift change for bedside report.Patient stated, "the tech gave me a heat pack to help with my belly pain and it burned me.I have a blister." rn ensured heat pack was off patient and left room to retrieve ice pack for patient.Upon return to patient's room, the rn assessed area of concern.Approximately 1cm unroofed blister noted above umbilicus that was not present prior to heat pack application.Surrounding tissue with erythema.Patient provided ice pack for mild discomfort of site.New wound assessment documented.

• Brand Name: THERMACARE HEATWRAPS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): PFIZER INC.; 275 n field drive; lake forest IL 60045
• MDR Report Key: 12318141
• MDR Text Key: 266390141
• Report Number: 12318141
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: EC7090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11315 DA
• Patient Weight: 127