MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-25 for LMA SUPREME 175040 manufactured by Teleflex Medical.
[17841467]
Pt has apparent lingual nerve injury following general anesthesia with airway management using a laryngeal mask airway, lma supreme size #4, for a 2 hour procedure. At this time, numbness persists. Product lot number presumed from other products in the department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033131 |
| MDR Report Key | 3493732 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-11-24 |
| Date of Event | 2013-11-12 |
| Date Added to Maude | 2013-12-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA SUPREME |
| Product Code | LMA |
| Date Received | 2013-11-25 |
| Model Number | LMA SUPREME |
| Catalog Number | 175040 |
| Lot Number | HMAA9J |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-11-25 |