MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2012-11-02 for ASPIRATING SYRINGE TYPE A 1004612 manufactured by Integra York, Pa Inc.
[21357570]
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
[21419040]
The reporter noted "cartridge was stuck in syringe. Doctor and assistant were punctured trying to remove. Cleaned wound and applied band-aid". Add'l info was requested by integra; not received at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2012-00091 |
| MDR Report Key | 2822494 |
| Report Source | 05,06,08 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-11-21 |
| Date Mfgr Received | 2012-10-10 |
| Date Added to Maude | 2012-11-08 |
| 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 | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099366828 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATING SYRINGE TYPE A |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EID |
| Date Received | 2012-11-02 |
| Catalog Number | 1004612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-02 |