MAUDE Adverse Event Report: BEST SANITIZERS, INC. ACECIDE-C; MEDICAL DEVICE STERILANT

Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Codes	Eye Burn (2523); Caustic/Chemical Burns (2549)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The staff was changing the liquid chemicals in the oer-pro machine.The bottom of the bottle would not fit into the tray.The staff member took a syringe and punctured the bottle to relieve pressure and cause the bottle to deflate.The bottle "exploded" onto the face and arms of the staff member.The staff was not wearing ppe and sustained a chemical burn.Used the eyewash station for ten minutes and yes eyes were still irritated and saw white spots.The staff member was treated at the hospital the day of the event and have had several trips to the eye doctor.No sustained damage.

• Brand Name: ACECIDE-C
• Common Device Name: MEDICAL DEVICE STERILANT
• Manufacturer (Section D): BEST SANITIZERS, INC.; 154 mullen dr; walton KY 41094
• Manufacturer (Section G): BEST SANITIZERS, INC.; 154 mullen dr; walton KY 41094
• Manufacturer Contact: cindi linville ; 154 mullen dr; walton, KY 41094 ; 8594855075
• MDR Report Key: 20802566
• Report Number: 3005763425-2024-00001
• Device Sequence Number: 9934485
• Product Code: MED
• UDI-Device Identifier: 10359900300008
• UDI-Public: 10359900300008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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
• 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: 11/21/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 23 YR
• Patient Sex: Male