MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-04-15 for EVALUEMED/D MILLER SZ 2 B3120 manufactured by Medical Devices Pvt, Ltd.
[1159408]
Acrylic bundle broke off in patient's mouth. No injury to patient. Piece was removed by hand from the patient's mouth, then patient's mouth was suctioned. Intubated using another blade. Patient was successfully intubated. No other complications due to device failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036445-2009-09021 |
| MDR Report Key | 1368644 |
| Report Source | 99 |
| Date Received | 2009-04-15 |
| Date of Report | 2009-04-15 |
| Date Facility Aware | 2009-03-10 |
| Report Date | 2009-04-15 |
| Date Reported to FDA | 2009-04-15 |
| Date Reported to Mfgr | 2009-04-15 |
| Date Added to Maude | 2009-04-28 |
| 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 | EVALUEMED/D MILLER SZ 2 |
| Generic Name | DISPOSABLE LARYNGOSCOPE BLADE |
| Product Code | EQN |
| Date Received | 2009-04-15 |
| Returned To Mfg | 2009-04-15 |
| Model Number | B3120 |
| Catalog Number | B3120 |
| Lot Number | 00M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVICES PVT, LTD |
| Manufacturer Address | SIALKIOT PK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-15 |