MAUDE Adverse Event Report: BEEKLEY CORPORATION COLDSPOT; COLD THERAPY PACK

Model Number	502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient had a breast biopsy where a coldspot 502 cold therapy pack was used afterwards.When the patient returned for their follow-up, the radiologist noticed the patient had blisters scarring and discoloration of the skin in the area of the biopsy.

• Brand Name: COLDSPOT
• Common Device Name: COLD THERAPY PACK
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer (Section G): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer Contact: kate chase ; 1 prestige lane; bristol, CT 06010 ; 8605834700
• MDR Report Key: 19124497
• Report Number: 9021987-2024-00001
• Device Sequence Number: 18213671
• Product Code: IMD
• UDI-Device Identifier: 00815137021084
• UDI-Public: 00815137021084
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: 502
• Device Catalogue Number: 502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown