MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for DECISLIDES manufactured by Fisher Scientific Co..
[136610893]
Lab received 3 boxes of fisherbrand decislides to read urine microscopics. All the slides were bowed making them impossible to focus and read.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8353501 |
| MDR Report Key | 8353501 |
| Date Received | 2019-02-20 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-20 |
| Report Date | 2018-11-29 |
| Date Reported to FDA | 2018-11-29 |
| Date Reported to Mfgr | 2019-02-20 |
| Date Added to Maude | 2019-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DECISLIDES |
| Generic Name | SLIDES, MICROSCOPE |
| Product Code | KEW |
| Date Received | 2019-02-20 |
| Lot Number | BP2152181 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER SCIENTIFIC CO. |
| Manufacturer Address | 755 STATE HIGHWAY 202 NORTH BRIDGEWATER NJ 08807 US 08807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |