MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-11-26 for MON-A-THERM? FOLEY CATHETERS WITH TEMPERATURE SENSORS 14FR 102201101463BI manufactured by Degania Silicone Ltd.
| Report Number | 8030107-2019-00023 |
| MDR Report Key | 9375690 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-11-26 |
| 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 | MRS. KATIA KAYAM |
| Manufacturer Street | DEGANIA BET |
| Manufacturer City | DEGANIA BET, JORDAN VALLEY 1513000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 1513000 |
| Manufacturer G1 | DEGANIA SILICONE LTD |
| Manufacturer Street | DEGANIA BET |
| Manufacturer City | DEGANIA BET, 1513000 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 1513000 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | RES 80641 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MON-A-THERM? FOLEY CATHETERS WITH TEMPERATURE SENSORS |
| Generic Name | 2W SIL.FOLEY CATH 14FR W/TEMP.SENSOR |
| Product Code | EYB |
| Date Received | 2019-11-26 |
| Returned To Mfg | 2018-02-25 |
| Model Number | 14FR |
| Catalog Number | 102201101463BI |
| Lot Number | V17011659 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGANIA SILICONE LTD |
| Manufacturer Address | DEGANIA BET DEGANIA BET, 1513000 IS 1513000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-26 |