MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-03 for OVATION DISTAL END CUTTERS BIG JOHN 200SV manufactured by Gac International.
[1320201]
It was reported that the tip of a pair of ovation cutters separated during use and was aspirated by the pt. The piece was retrieved by means of an endoscopic procedure and the pt stayed in the hosp overnight for observation.
Patient Sequence No: 1, Text Type: D, B5
[8430259]
Because a serious injury resulted in this case, this event meets the criteria for reportability (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086211-2010-00010 |
| MDR Report Key | 1600528 |
| Report Source | 05 |
| Date Received | 2010-02-03 |
| Date of Report | 2010-01-08 |
| Date of Event | 2009-09-24 |
| Date Mfgr Received | 2010-01-08 |
| Date Added to Maude | 2010-02-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILA. ST, STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | ORTHODENTAL INTL., INC. |
| Manufacturer Street | 2306 M.L. KING, SUITE 1 |
| Manufacturer City | CALEXICO CA 92231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVATION DISTAL END CUTTERS |
| Product Code | EJB |
| Date Received | 2010-02-03 |
| Model Number | NA |
| Catalog Number | BIG JOHN 200SV |
| Lot Number | 00-26 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | BOHEMIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 16 | 1. Hospitalization; 2. Required No Informationntervention | 2010-02-03 |