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 PROSEAL REU INTRODUCER (3, 4 & 5) 151030 manufactured by Teleflex Medical.
[154121618]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[154121619]
The customer reported: "it was about to be used on a patient for introducing a proseal in theatre but the problem was seen before use. " "the anaesthetic nurse involved stated that when she opened it and tried to put it into the proseal stated she had difficulty putting it in, when she looked closer noticed it had separated - the blue part from the metal plate. ". The patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00034 |
| MDR Report Key | 8887779 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-13 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-09-10 |
| 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 PROSEAL REU INTRODUCER (3, 4 & 5) |
| Generic Name | AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY |
| Product Code | CAE |
| Date Received | 2019-08-13 |
| Returned To Mfg | 2019-08-07 |
| Catalog Number | 151030 |
| 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 | 2019-08-13 |