MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-02-21 for RUSCH LARYNGOFLEX WITH VALVE 121181-000080 manufactured by Teleflex Medical.
| Report Number | 9610520-2020-00002 |
| MDR Report Key | 9741635 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2018-11-20 |
| Date Added to Maude | 2020-02-21 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | WILLY-RUSCH-STR. 4 - 10 |
| Manufacturer City | 71394 KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH LARYNGOFLEX WITH VALVE |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONN |
| Product Code | BTO |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | 121181-000080 |
| Lot Number | 18471 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 71394 KERNEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |