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

Model Number 502

Device Problem Insufficient Information (3190)

Patient Problem Blister (4537)

Event Date 03/26/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 340375993
• Report Number: 9021987-2024-00001
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00815137021084
• UDI-Public: 00815137021084
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 502
• Device Catalogue Number: 502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other