MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-04-28 for JAKO LARYNGEAL PROBE, ANGLED BE2847 manufactured by .
Report Number | 1423507-2000-00116 |
MDR Report Key | 275840 |
Report Source | 06 |
Date Received | 2000-04-28 |
Date of Report | 2000-04-28 |
Date of Event | 2000-02-11 |
Date Mfgr Received | 2000-04-25 |
Date Added to Maude | 2000-05-03 |
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 | 0 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | PATRICIA SHARPE-GREGG |
Manufacturer Street | 1500 WAUKEGAN ROAD |
Manufacturer City | MCGAW PARK IL 60085 |
Manufacturer Country | US |
Manufacturer Postal | 60085 |
Manufacturer Phone | 8475783636 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | JAKO LARYNGEAL PROBE, ANGLED |
Generic Name | INSTRUMENT |
Product Code | KAK |
Date Received | 2000-04-28 |
Model Number | BE2847 |
Catalog Number | BE2847 |
Lot Number | UNK |
ID Number | N/A |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 263700 |
Baseline Brand Name | JAKO LARYNGEAL PROBE, ANGLED |
Baseline Generic Name | INSTRUMENT |
Baseline Model No | BE2847 |
Baseline Catalog No | BE2847 |
Baseline Device Family | INSTRUMENT |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | Y |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2000-04-28 |