MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-01-12 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi Norwalk.
[579020]
Patient intubated, bullard blade extender was inadvertently left in place, unk to anesthesia. Patient's anesthetic was completed without incident, patient extubated in pacu without a problem. Upon transfer to the floor, the patient coughed up a blade extender. Physician was notified and saw patient. No apparent patient injury. Facility has filed a medwatch report with the fda. The device is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[7818420]
Since the subject device was not returned to acmi for analysis, no conclusions can be drawn at this time regarding to root cause of the event. Should the device be made available, acmi will reopen the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2007-00001 |
| MDR Report Key | 813892 |
| Report Source | 06,07 |
| Date Received | 2007-01-12 |
| Date of Report | 2007-01-11 |
| Date of Event | 2006-10-31 |
| Date Facility Aware | 2006-12-11 |
| Report Date | 2007-01-11 |
| Date Mfgr Received | 2006-12-11 |
| Date Added to Maude | 2007-02-12 |
| 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 | 0 |
| Manufacturer Contact | TERRANCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| 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 | 500 |
| Product Code | EQN |
| Date Received | 2007-01-12 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | 1655606H |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 801381 |
| 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 | 2007-01-12 |