MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-02-11 for LMA FLEXIBLE SU SIZE 3 115030 manufactured by Teleflex Medical.
[183106437]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183106438]
Complaint reported as: "anaesthesiologist informed us that upon preparing the product for usage, he noticed that the product swelled from one side so he stopped and didn't use it". No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2020-00003 |
| MDR Report Key | 9695985 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-02-11 |
| 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 FLEXIBLE SU SIZE 3 |
| Generic Name | AIRWAY, OROPHARYNGEAL, ANESTHE |
| Product Code | CAE |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 115030 |
| Lot Number | PDAC25 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-11 |