MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-07-13 for ADULT BULLARD LARYNGOSCOPE LARS-A manufactured by .
[15312008]
The device is not being returned for eval. Without the instrument return, a full investigation can not be completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2007-00007 |
| MDR Report Key | 904471 |
| Report Source | 06 |
| Date Received | 2007-07-13 |
| Date Facility Aware | 2007-05-02 |
| Report Date | 2007-05-30 |
| Date Mfgr Received | 2007-06-19 |
| Date Added to Maude | 2007-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE SCHULZ |
| Manufacturer Street | 6655 WEDGEWOOD RD., STE 160 |
| Manufacturer City | MAPLE GROVE MN 553113502 |
| Manufacturer Country | US |
| Manufacturer Postal | 553113502 |
| Manufacturer Phone | 7634163032 |
| Manufacturer G1 | GYRUS ACMI, INC. - 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 | ADULT BULLARD LARYNGOSCOPE |
| Generic Name | ADULT BULLARD ELITE LARYNGOSCOPE |
| Product Code | EQN |
| Date Received | 2007-07-13 |
| Model Number | LARS-A |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 874651 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-13 |