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 2019-08-13 for LMA PROTECTOR CUFF PILOT SIZE 4 192040 manufactured by Teleflex Medical.
[182599964]
(b)(4). It is unknown if a sample device is available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[182599965]
The complaint was reported as "lma could not be inflated/blocked". The customer reported "the defect occurred during use, i. E. Immediately after the installation of the lma the cuff could not be inflated. It was very obvious that the spiral in the "cuff-pilot" stucked and could not be loosened by inflation, means the cuff could not be inflated. " the cuff was not tested prior to use. There was no patient injury, but it was reported ventilation was interrupted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00035 |
| MDR Report Key | 8889590 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-13 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-06-28 |
| Date Mfgr Received | 2019-09-09 |
| Date Added to Maude | 2019-08-13 |
| 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 PROTECTOR CUFF PILOT SIZE 4 |
| Generic Name | LMA PROTECTOR |
| Product Code | CAE |
| Date Received | 2019-08-13 |
| Returned To Mfg | 2019-08-14 |
| Catalog Number | 192040 |
| Lot Number | LMBRQW |
| Device Expiration Date | 2019-09-28 |
| 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 | 2019-08-13 |