MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-28 for DIRECTCHECK QUALITY CONTROL DCJACT-A manufactured by International Technidyne Corp..
[4335116]
Healthcare professional reports a end user was injured on her right thumb when using the direct check quality control. The end user was not using the protective sleeve at the time of incident. She performed standard first aid to the affected area. No report of serious injury or administration of medical treatment. Per follow-up communication, the end user advised the affected areas has healed.
Patient Sequence No: 1, Text Type: D, B5
[11596463]
(b)(4). Actual device not evaluated. Process evaluation performed. Device history records reviewed and found to meet release specifications. No related ncrs or current complaint trends identified. Conclusion - end user was not using the protective sleeve at the time of injury. The direct check protective sleeve is provided as a means to reduce probability of cuts. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2014-00001 |
| MDR Report Key | 3720885 |
| Report Source | 05,06 |
| Date Received | 2014-02-28 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-04-29 |
| 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 | ELEANOR FOX |
| Manufacturer Street | 20 CORP PLACE S |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer G1 | INTERNATIONAL TECHNIDYNE CORP. |
| 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 |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2014-02-28 |
| Catalog Number | DCJACT-A |
| Lot Number | L2DCA036 |
| Device Expiration Date | 2014-04-30 |
| 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 | 23 NEVSKY ST. EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-28 |