MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2004-06-21 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi Norwalk.
[377192]
The disposable blade extender for bullard rigid laryngoscope came off laryngoscope and became lodged in pt's throat. Blade extender had to be manually extracted to prevent harm to the pt. There is no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2004-00041 |
| MDR Report Key | 588744 |
| Report Source | 00,06 |
| Date Received | 2004-06-21 |
| Date of Report | 2004-06-18 |
| Date of Event | 2004-05-15 |
| Date Facility Aware | 2004-05-17 |
| Report Date | 2004-06-18 |
| Date Reported to Mfgr | 2004-06-03 |
| Date Mfgr Received | 2004-06-03 |
| Date Added to Maude | 2005-04-08 |
| 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 | JOHN RING, JR. |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 017722104 |
| Manufacturer Country | US |
| Manufacturer Postal | 017722104 |
| Manufacturer Phone | 5088042697 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 N PLEASANT ST |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLADE EXTENDER KIT |
| Generic Name | LARYNGOSCOPE, BULLARD |
| Product Code | EQN |
| Date Received | 2004-06-21 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 578540 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | * NORWALK OH * US |
| Baseline Brand Name | BLADE EXTENDER FOR BULLARD LARYNGOSCOPE |
| Baseline Generic Name | LARYNGOSCOPE |
| Baseline Model No | LAR-AE |
| Baseline Catalog No | LAR-AE |
| Baseline ID | NA |
| Baseline Device Family | LARYNGOSCOPE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K883819 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-06-21 |