MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-16 for PREPSTART 200259-00 manufactured by Danville Materials.
[82862841]
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.
Patient Sequence No: 1, Text Type: D, B5
[110916215]
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.
Patient Sequence No: 1, Text Type: N, H10
[110916216]
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.
Patient Sequence No: 1, Text Type: D, B5
[114850638]
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.
Patient Sequence No: 1, Text Type: N, H10
[114850639]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023950-2017-00255 |
| MDR Report Key | 6799440 |
| Date Received | 2017-08-16 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS OLIVIA KIM |
| Manufacturer Street | 2875 LOKER AVENUE EAST |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 7607437744 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREPSTART |
| Generic Name | AIRBRUSH |
| Product Code | KOJ |
| Date Received | 2017-08-16 |
| Returned To Mfg | 2017-08-14 |
| Model Number | 200259-00 |
| Catalog Number | 200259-00 |
| Lot Number | NOT PROVIDED |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANVILLE MATERIALS |
| Manufacturer Address | 2875 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-08-16 |