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 2019-07-30 for LMA GASTRO CUFF PILOT SIZE 4 1E5040 manufactured by Teleflex Medical.
[152657259]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[152657260]
It was reported that the balloon of the device was stuck in the larynx of the patient because the doctor was unable to deflate the balloon. The doctor has stated that it was user error as he acknowledged he did not use the correct syringe and did not follow the ifu guidelines. It was also reported that "during the incident he pulled on the device to remove the tube with the balloon inflated but there was no pain for any patient. " since the event, an in-service has been performed with the doctor. No patient injury/harm reported. The condition of the patient was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00031 |
| MDR Report Key | 8841660 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-30 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-07-31 |
| Date Added to Maude | 2019-07-30 |
| 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 GASTRO CUFF PILOT SIZE 4 |
| Generic Name | LMA GASTRO CUFF PILOT |
| Product Code | CAE |
| Date Received | 2019-07-30 |
| Catalog Number | 1E5040 |
| Lot Number | NMCPRQ |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2019-07-30 |