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 2019-12-28 for LMA PROSEAL, REU, SIZE 5 (150050) 15150 manufactured by Teleflex Medical.
[182600476]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182600477]
The complaint is reported as: "cuff breakage detected when applying lubrication. Record card was not returned from the facility. No information on how many times they have used before the alleged event. Dried lubrication on the product. " no patient involvement. Issue detected prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00056 |
| MDR Report Key | 9528317 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-12-28 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2019-12-28 |
| 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 PROSEAL, REU, SIZE 5 (150050) |
| Generic Name | LMA PROSEAL |
| Product Code | CAE |
| Date Received | 2019-12-28 |
| Returned To Mfg | 2019-12-17 |
| Catalog Number | 15150 |
| Lot Number | MFADSB |
| 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 | 2019-12-28 |