MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-09 for FOLEY CATHETER WITH TEMPERATURE SENSOR 81-080408 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
| Report Number | 2320762-2019-00006 |
| MDR Report Key | 8977597 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-09 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-08-14 |
| Date Added to Maude | 2019-09-09 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1595 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER WITH TEMPERATURE SENSOR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2019-09-09 |
| Returned To Mfg | 2019-08-23 |
| Model Number | 81-080408 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Address | GLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-09 |