MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-24 for LMA SUPREME SIZE 2 175020 manufactured by Teleflex Medical.
[182597260]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182597261]
Customer reported an anesthesia machine detected a leak while the device was used on a patient. The mask was changed and it was reported the user observed a detached mask in the cuff area. No patient harm or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00042 |
| MDR Report Key | 9112536 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-24 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-10-11 |
| Date Added to Maude | 2019-09-24 |
| 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 2 |
| Generic Name | LMA SUPREME |
| Product Code | CAE |
| Date Received | 2019-09-24 |
| Catalog Number | 175020 |
| Lot Number | NMA37K |
| 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 | 2019-09-24 |