MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-26 for DIRECTCHECK QUALITY CONTROL DCPRO-A manufactured by International Technidyne Corporation.
[2906126]
Healthcare professional reports end user was injured on his right thumb from a piece of glass while preparing the directcheck quality control. There was no report of serious injury or administration of medical treatment.
Patient Sequence No: 1, Text Type: D, B5
[10141330]
(b)(4). Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2012-00008 |
| MDR Report Key | 2765216 |
| Report Source | 06 |
| Date Received | 2012-09-26 |
| Date of Report | 2012-08-31 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-08-31 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-01-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | EDISON 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 | 2012-09-26 |
| Catalog Number | DCPRO-A |
| Lot Number | G2DAP010 |
| Device Expiration Date | 2013-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORPORATION |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-26 |