MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for LMA PROSEAL REU INTRODUCER (3, 4 & 5) 151030 manufactured by Teleflex Medical.
[177666989]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177666990]
Customer complaint alleges "the rubber on the end of the proseal introducer has become detached from the metal framework". The reported issue was found in preparation for use. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2020-00001 |
| MDR Report Key | 9538083 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-01-02 |
| Returned To Mfg | 2019-12-30 |
| Catalog Number | 151030 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| 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 | 2020-01-02 |