D
Patient 1
CUSTOMER INDICATED THAT THERE WAS A HEAVY EXC ESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.
MAUDE MDR 6799440
- MDR report key
- 6799440
- Report number
- 2023950-2017-00255
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-17
- Date received
- 2017-08-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS OLIVIA KIM
- Address
- 2875 LOKER AVENUE EAST CARLSBAD CA 92010 US
- Phone
- 760-760-7607
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PREPSTART | AIRBRUSH | DANVILLE MATERIALS | KOJ | 200259-00 | 200259-00 | NOT PROVIDED | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-16 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
FINAL EVALUATION OF DEVICE WAS PERFORMED. WEAR OF THE PINCH VALVE SPING AND FOOT PEDAL VALVE WAS OBSERVED. PROBABLE CAUSE: INSTRUCTIONS FOR USE INDICATES THAT EYE PROTECTION SHOULD BE WORN BY PATIENT AND STAFF DURING AIR ABRASIAN USE. PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR DURING AIR ABRASIAN USE. (B)(4) MATERIALS REPRESENTATIVE FOLLOWED-UP WITH PATIENT STATUS. PATIENT FOLLOWED EYE WASH PROTOCOL FOR 3 MINUTES WITH NO COMPLICATIONS. INSTRUCTION FOR USE ALSO INDICATES THAT THE PINCH VALVE SHOULD BE INSPECTED AFTER EVERY 6 MONTHS OF USE FOR SIGNS OF WEAR. UNDER NORMAL USE THE PREPSTART PINCH VALVE TUBE WILL LAST A MINIMUM OF ONE YEAR. PROBABLE CAUSE OF WORN VALVES MAY BE BECAUSE OF FAILURE TO INSPECT THE VALVES FOR SIGNS OF WEAR.
D
Patient 1
CUSTOMER INDICATED THAT THERE WAS A HEAVY EXCESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.
N
Patient 1
FINAL EVALUATION OF DEVICE WAS PERFORMED. WEAR OF THE PINCH VALVE SPING AND FOOT PEDAL VALVE WAS OBSERVED. PROBABLE CAUSE: INSTRUCTIONS FOR USE INDICATES THAT EYE PROTECTION SHOULD BE WORN BY PATIENT AND STAFF DURING AIR ABRASIAN USE. PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR DURING AIR ABRASIAN USE. (B)(4) MATERIALS REPRESENTATIVE FOLLOWED-UP WITH PATIENT STATUS. PATIENT FOLLOWED EYE WASH PROTOCOL FOR 3 MINUTES WITH NO COMPLICATIONS. INSTRUCTION FOR USE ALSO INDICATES THAT THE PINCH VALVE SHOULD BE INSPECTED AFTER EVERY 6 MONTHS OF USE FOR SIGNS OF WEAR. UNDER NORMAL USE THE PREPSTART PINCH VALVE TUBE WILL LAST A MINIMUM OF ONE YEAR. PROBABLE CAUSE OF WORN VALVES MAY BE BECAUSE OF FAILURE TO INSPECT THE VALVES FOR SIGNS OF WEAR.
D
Patient 1
CUSTOMER INDICATED THAT THERE WAS A HEAVY EXCESS FLOW OF ALUMINUM OXIDE WHEN THE PEDAL WAS STEPPED-ON. CUSTOMER INDICATED THAT ALUMINUM OXIDE MATERIAL REACHED THE PATIENT'S EYES. THE PATIENT WAS NOT WEARING PROTECTIVE EYEWEAR.