MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-07-26 for VITROS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics.
[19158202]
A customer was cut on the hand while opening a diluent bottle of calibrator kit 4 or 2. The customer received medical attention for the cut, where the hand was washed and bandaged, and the employee received a tetanus shot. The employee was released to return to work. No complications have been reported. Exposure to the bottle contents could cause irritation to the skin, eyes and respiratory system. This is being reported as an adverse event because the subject received a tetanus shot due to the injury. This report corresponds to ortho clinical diagnostics inc.
Patient Sequence No: 1, Text Type: D, B5
[19442749]
Investigation into this event determined that the bottle broke while the metal seal was being removed. Prior to breakage, there was no evidence of the bottle being damaged. The root cause of this event is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2007-00212 |
| MDR Report Key | 886445 |
| Report Source | 05 |
| Date Received | 2007-07-26 |
| Date of Report | 2007-06-28 |
| Date of Event | 2007-06-28 |
| Date Mfgr Received | 2007-06-28 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2007-09-18 |
| 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 | THOMAS SMITH |
| Manufacturer Street | 100 INDIGO CREEK DR |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854533735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CALIBRATOR KIT 2 |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LBR |
| Date Received | 2007-07-26 |
| Model Number | NA |
| Catalog Number | 1662659 |
| Lot Number | 0286 |
| ID Number | NA |
| Device Expiration Date | 2008-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867550 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR ROCHESTER NY 146265101 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-26 |