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 2019-10-11 for LMA PROTECTOR MEDICAL UNKNOWN manufactured by Teleflex Medical.
[183106550]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183106551]
Customer reported "unable to take any air out of the cuff" during demonstration on a mannequin. The device was inserted into the mannequin and the cuff pilot marker was in the red zone. The device was removed from the mannequin and another attempt was made to remove air. The cuff pilot marker remained in the red zone and would not come back down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00046 |
| MDR Report Key | 9181536 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-10-11 |
| 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 PROTECTOR |
| Generic Name | LMA PROTECTOR |
| Product Code | CAE |
| Date Received | 2019-10-11 |
| Catalog Number | MEDICAL UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |