MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for DROPSAFE UNKNOWN 8162 manufactured by Htl-strefa S.a..
| Report Number | 9613304-2020-00009 |
| MDR Report Key | 9872329 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ALEKSANDRA PRAZMOWSKA-WILANOWSKA |
| Manufacturer Street | ADAMOWEK 7 |
| Manufacturer City | OZORKOW, 95-035 |
| Manufacturer Country | PL |
| Manufacturer Postal | 95-035 |
| Manufacturer G1 | HTL-STREFA S.A. |
| Manufacturer Street | ADAMOWEK 7 |
| Manufacturer City | OZORKOW, 95-035 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 95-035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DROPSAFE |
| Generic Name | SAFETY PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-24 |
| Model Number | UNKNOWN |
| Catalog Number | 8162 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HTL-STREFA S.A. |
| Manufacturer Address | ADAMOWEK 7 OZORKOW, 95-035 PL 95-035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |