MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-19 for PEDO CROWN-FESTOONING SCS 9D-118 manufactured by Integra, York - Imiltex.
[2019490]
Facility initially reported the items have broken tips. No pt injury. On (b)(6) 2011, customer reports that this device is used to manipulate crowns and the doctor is concerned that there is potential for the tips to be swallowed when they break off.
Patient Sequence No: 1, Text Type: D, B5
[9131464]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00031 |
| MDR Report Key | 2117133 |
| Report Source | 06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-05-19 |
| Date Mfgr Received | 2011-05-09 |
| Date Added to Maude | 2011-07-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDO CROWN-FESTOONING SCS |
| Generic Name | M9 - ORAL-MAXILLO |
| Product Code | ELZ |
| Date Received | 2011-05-19 |
| Catalog Number | 9D-118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-19 |