MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-03-25 for DIRECTCHECK QUALITY CONTROL DCPRO-A manufactured by International Technidyne Corp..
[3326536]
Qc technician reports injury to his left hand from a piece of glass when activating the directcheck quality control. He was evaluated at the local hospital. No report of serious injury.
Patient Sequence No: 1, Text Type: D, B5
[10652061]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00002 |
| MDR Report Key | 3027360 |
| Report Source | 00 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-02-25 |
| Date of Event | 2013-02-25 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-05-24 |
| 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 | LAWRENCE PICCIANO |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTCHECK QUALITY CONTROL |
| Product Code | GGN |
| Date Received | 2013-03-25 |
| Catalog Number | DCPRO-A |
| Lot Number | J2DAP019 |
| Device Expiration Date | 2014-04-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-25 |