MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-06-22 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi Norwalk.
[482591]
During an attempt to intubate the patient using a fiberoptic scope with a bullard laryngoscope, the patient's teeth clamped down on the bullard blade, dislodging the disposable blade extender. It was swallowed by the patient and lodged in the esophagus. Original surgical procedure was aborted and the patient returned to surgery later that same day for removal of the foreign body. Patient was sent to the icu. Patient unable to be weaned from ventilator and was transferred to another hospital in 2006 at the family's request. Medwatch copy was received in the mail on 5/26/06, it is not being reported to the fda. The device is available for on-site inspection only.
Patient Sequence No: 1, Text Type: D, B5
[7784834]
To date acmi has not been afforded an opportunity to evaluate the subject device, and as a result no conclusions can be made at this time. Upon performance of such an evaluation, acmi will file a follow up report with the agency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2006-00003 |
| MDR Report Key | 732271 |
| Report Source | 06 |
| Date Received | 2006-06-22 |
| Date of Report | 2006-06-21 |
| Date of Event | 2006-05-05 |
| Date Facility Aware | 2006-05-26 |
| Report Date | 2006-06-21 |
| Date Mfgr Received | 2006-05-26 |
| Date Added to Maude | 2006-07-10 |
| 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 | TERRENCE 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 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 | 500 |
| Product Code | EQN |
| Date Received | 2006-06-22 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | 1535485J |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 720579 |
| 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 | 2006-06-22 |