MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-28 for CONFIDENCE KIT, NO NEEDLES 283913000 manufactured by Medos International Sàrl Ch.
| Report Number | 1526439-2020-00634 |
| MDR Report Key | 9772178 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-02-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIDENCE KIT, NO NEEDLES |
| Generic Name | POLYMETHYLMETHACRYLATE BONE CEMENT |
| Product Code | NDN |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-10 |
| Model Number | 283913000 |
| Catalog Number | 283913000 |
| Lot Number | 244229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |