MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-25 for MICROPREP DIRECTOR+ 12197 manufactured by Lares Research, Inc..
[1183753]
In 2009: dr. Was using the air abrasion unit on a girl. During the procedure, her cheek was lacerated, and she had what appeared to be a hypersensitivity reaction with eye swelling. The symptoms worsened with further swelling and "wrinkling and crinkling, almost like rice krispies" down into her neck. The girl spent the night in the pediatric intensive care unit at the hospital. As of this morning, dr. Stated that her condition has improved, and is due to be released from the hospital this afternoon. I told him we would call if any additional information was needed. Dr. Acknowledged knowing that aluminum oxide is harmless, and he didn't need another msds sheet sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916440-2009-00001 |
| MDR Report Key | 1486003 |
| Report Source | 05 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-09-25 |
| Date of Event | 2009-09-16 |
| Date Mfgr Received | 2009-09-17 |
| Device Manufacturer Date | 1998-10-21 |
| Date Added to Maude | 2009-10-01 |
| 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 | 0 |
| Manufacturer Contact | JASON ORGAIN |
| Manufacturer Street | 295 LOCKHEED AVE. |
| Manufacturer City | CHICO CA 95973 |
| Manufacturer Country | US |
| Manufacturer Postal | 95973 |
| Manufacturer Phone | 5303451767 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROPREP DIRECTOR+ |
| Generic Name | DENTAL AIR ABRASION UNIT/ AIRBRUSH; KOJ |
| Product Code | KOJ |
| Date Received | 2009-09-25 |
| Catalog Number | 12197 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LARES RESEARCH, INC. |
| Manufacturer Address | 295 LOCKHEED AVE. CHICO CA 95973 US 95973 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-09-25 |