MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-13 for LMA SUPREME SIZE 1.5 175015 manufactured by Teleflex Medical.
[148160722]
Qn# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[148160723]
The complaint is reported as: "the user was unable to insert an esophagus tube into drain tube. Therefore, the unit was replaced with a new one". No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00017 |
| MDR Report Key | 8697012 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-13 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-07-12 |
| Date Added to Maude | 2019-06-13 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | THE LARYNGEAL MASK COMPANY |
| Manufacturer Street | 6 BATTERY ROAD #07-02 |
| Manufacturer City | SINGAPORE 049909 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 049909 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA SUPREME SIZE 1.5 |
| Generic Name | LMA SUPREME |
| Product Code | CAE |
| Date Received | 2019-06-13 |
| Returned To Mfg | 2019-07-03 |
| Catalog Number | 175015 |
| Lot Number | MMA8JT |
| 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 | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-13 |