MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-19 for UNKNOWN BEACON manufactured by Covidien Lp Barrx.
| Report Number | 3004904811-2020-00003 |
| MDR Report Key | 9857102 |
| Report Source | LITERATURE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-19 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | COVIDIEN LP BARRX |
| Manufacturer Street | COVIDIEN GI SOLUTIONS |
| Manufacturer City | SUNNYVALE CA 940854022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940854022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN BEACON |
| Product Code | NEU |
| Date Received | 2020-03-19 |
| Model Number | UNKNOWN BEACON |
| Catalog Number | UNKNOWN BEACON |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP BARRX |
| Manufacturer Address | COVIDIEN GI SOLUTIONS SUNNYVALE CA 940854022 US 940854022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-19 |