MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-02-27 for LARYNGOSCOPE BLADE, MAC2, DISPOSABLE, GREEN 301-B3020 manufactured by Medical Devices (pvt) Ltd.
[15932775]
While anesthesiologist was trying to intubate pt the plastic tube light on the blade broke and plastic was in pts back area of mouth. Anesthesiologist removed plastic from pt mouth and then proceeded to go back in and intubate pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036445-2014-00002 |
| MDR Report Key | 3670463 |
| Report Source | 99 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-01-31 |
| Date Facility Aware | 2014-02-05 |
| Report Date | 2014-02-26 |
| Date Reported to FDA | 2014-02-26 |
| Date Reported to Mfgr | 2014-02-26 |
| Date Added to Maude | 2014-03-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARYNGOSCOPE BLADE, MAC2, DISPOSABLE, GREEN |
| Generic Name | DISPOSABLE LARYNGOSCOPE BLADE |
| Product Code | EQN |
| Date Received | 2014-02-27 |
| Catalog Number | 301-B3020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVICES (PVT) LTD |
| Manufacturer Address | UGOKI, SIALKOT PK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-27 |