MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-22 for VIDEO MEDIASTINOSCOPE 8783.411 manufactured by Richard Wolf Gmbh.
[17104940]
At the end of a bronchoscopy procedure a 1/4 inch size burn was noticed on the outside of the patient's throat. The area was dressed and covered. There are no further consequences known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2006-00002 |
| MDR Report Key | 679888 |
| Report Source | 06 |
| Date Received | 2006-02-22 |
| Date of Report | 2006-02-22 |
| Date of Event | 2006-01-24 |
| Date Facility Aware | 2006-01-24 |
| Report Date | 2006-02-22 |
| Date Mfgr Received | 2006-01-24 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2006-03-01 |
| 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 | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STR. 32 |
| Manufacturer City | KNITTLINGEN D 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDEO MEDIASTINOSCOPE |
| Generic Name | VIDEO MEDIASTINOSCOPE |
| Product Code | EWY |
| Date Received | 2006-02-22 |
| Returned To Mfg | 2006-02-06 |
| Model Number | 8783.411 |
| Catalog Number | 8783.411 |
| Lot Number | 370100 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2.4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669164 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | * KNITTLINGEN GM |
| Baseline Brand Name | VIDEO MEDIASTINOSCOPE |
| Baseline Generic Name | MEDIASTINOSCOPE |
| Baseline Model No | 8783.411 |
| Baseline Catalog No | 8783.411 |
| Baseline Device Family | MEDIASTINOSCOPES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971166 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-22 |