MAUDE Adverse Event Report: BEEKLEY CORPORATION POINTGUARDS; Tape and bandage, adhesive

Model Number	315
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A temporary mark cover fell off during radiation treatment resulting in loss of the mark.As a result, ct simulation was repeated.

• Brand Name: POINTGUARDS
• Common Device Name: Tape and bandage, adhesive
• Manufacturer (Section D): BEEKLEY CORPORATION; 1 prestige lane; bristol CT 06010
• Manufacturer (Section G): BEEKLEY CORPORATION; 1prestige lane; bristol CT 06010
• Manufacturer Contact: kate chase ; 1 prestige lane; bristol, CT 06010 ; 8605834700
• MDR Report Key: 25376907
• Report Number: 9021987-2026-00002
• Device Sequence Number: 16089945
• Product Code: KGX
• UDI-Device Identifier: 00815137020254
• UDI-Public: (01)00815137020254(10)315.26000225
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/03/2026

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: 315
• Device Catalogue Number: 315
• Device Lot Number: 315.26000225
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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