MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-11-02 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi Norwalk.
[16404672]
Plastic tip somehow became dislodged and wasn't noticed by the staff. Pt. Complained of a sore throat after procedure. Given throat spray, etc. Pt. Was later given medications and began to choke and coughed up 1" x 3" piece of plastic. Note: acmi was notified via medwatch report, see addt'l communication log.
Patient Sequence No: 1, Text Type: D, B5
[16657530]
Customer not returning product. Evaluation not performed. The problem likely due to user error. Historical data indicates that problems of this nature are the result of incorrect assembly of the device by the user. Device labeling has explicit instructions regarding the proper assembly of the blade extender and the laryngoscope blade. When properly assembled, a blade extender remover (cat. No lar-er) used to remove the extender for the laryngoscope. This blade is nearly impossible to remove with bare hands, impossible to fall off if installed properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2004-00071 |
| MDR Report Key | 826478 |
| Report Source | 07 |
| Date Received | 2004-11-02 |
| Date of Event | 2004-09-30 |
| Date Facility Aware | 2004-10-06 |
| Date Added to Maude | 2007-03-13 |
| 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 | GRACIELA DENIS |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042670 |
| 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 | 2004-11-02 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 813865 |
| 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 | 2004-11-02 |