MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-05 for SPECIMEN GATE LABORATORY 5002-0180 manufactured by Wallac Oy, Subsidiary Of Perkinelmer.
| Report Number | 8043909-2020-00001 |
| MDR Report Key | 9673899 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-09-22 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2018-11-04 |
| Date Added to Maude | 2020-02-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS RINA WAHLROOS |
| Manufacturer Street | MUSTIONKATU 6 |
| Manufacturer City | TURKU, FI-20750 |
| Manufacturer Country | FI |
| Manufacturer Postal | FI-20750 |
| Manufacturer G1 | WALLAC OY, SUBSIDIARY OF PERKINELMER |
| Manufacturer Street | MUSTIONKATU 6 |
| Manufacturer City | TURKU, 20750 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 20750 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECIMEN GATE LABORATORY |
| Generic Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| Product Code | JQP |
| Date Received | 2020-02-05 |
| Model Number | 5002-0180 |
| Catalog Number | 5002-0180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALLAC OY, SUBSIDIARY OF PERKINELMER |
| Manufacturer Address | MUSTIONKATU 6 TURKU, 20750 FI 20750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |