MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2013-03-29 for DIRECTCHECK QUALITY CONTROL DCPRO-N manufactured by International Technidyne Corp..
[3206170]
Distributor reports end user was injured on their right thumb from a glass splinter which punctured through the directcheck quality control during activation of the control vial. End user flushed the wound immediately with water and disinfectant. No report of serious injury, or administration of medical treatment. This event occurred outside of the united states.
Patient Sequence No: 1, Text Type: D, B5
[10641320]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00003 |
| MDR Report Key | 3032775 |
| Report Source | 01,06,08 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-03-04 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-03-04 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-05-30 |
| 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 | 2013-03-29 |
| Catalog Number | DCPRO-N |
| Lot Number | L2DCP027 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-03-29 |