MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-06 for DIPPER URINE DIPSTICK CONTROL 1440-01 manufactured by Quantimetrix Corporation.
[6023067]
Per the office manager at the facility - the glass vial containing quality control material, dipper urine dipstick control broke in the medical assistant's hand when she attempted to twist off the cap. The cut occurred on the index finger on right hand. The office manager mentioned that the cut was addressed by a physician and required only a band aid and was considered a little minor cut. The medical assistant was not wearing gloves when she attempted to twist off cap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020715-2015-00001 |
| MDR Report Key | 4898202 |
| Report Source | 05 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-06-05 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KALYNA SNYLYK |
| Manufacturer Street | 2005 MANHATTAN BEACH BLVD |
| Manufacturer City | REDONDO BEACH CA 90278 |
| Manufacturer Country | US |
| Manufacturer Postal | 90278 |
| Manufacturer Phone | 3105360006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIPPER URINE DIPSTICK CONTROL |
| Generic Name | URINALYSIS CONTROL, 862.1660 |
| Product Code | CEK |
| Date Received | 2015-07-06 |
| Catalog Number | 1440-01 |
| Lot Number | 44822 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUANTIMETRIX CORPORATION |
| Manufacturer Address | 2005 MANHATTAN BEACH BLVD. REDONDO BEACH CA 90278 US 90278 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |