MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-11 for LMA UNIQUE (SILICONE CUFF) CPV SIZE 5 105200-000050 manufactured by Teleflex Medical.
[166754769]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[166754770]
Customer reported the device would not seat well upon three attempts by experienced providers for a general anesthesia case. Patient had to be intubated and was given a muscle relaxant. Customer reported that upon emergence the patient coughed against the ett and desaturated into the 80's. The anesthesiologist was called to the room and reintroduced anesthesia to attempt a smoother wake up. The patient again had desaturation into the 80's. Patient was eventually woken up with no long term harm, but the difficulty with emergence added 15 minutes to the or time at the end of the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00341 |
| MDR Report Key | 9181135 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-11-05 |
| 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 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA UNIQUE (SILICONE CUFF) CPV SIZE 5 |
| Generic Name | LMA UNIQUE |
| Product Code | CAE |
| Date Received | 2019-10-11 |
| Catalog Number | 105200-000050 |
| 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 | 1. Required No Informationntervention | 2019-10-11 |