MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-01-17 for * manufactured by *.
[17234377]
Device will not be returned due to end user cannot determine which cord was involved in the incident.
Patient Sequence No: 1, Text Type: N, H10
[17248624]
It was reported that at the end of the procedure, the physician handed the scope to the scrub tech and asked for the light to be turned off. The light cord was put down on the drape. Moments later a black hole in the drape was noticed. The drape was removed and the pt was found to have a burn on the lower lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2007-00001 |
| MDR Report Key | 813648 |
| Report Source | 06 |
| Date Received | 2007-01-17 |
| Date of Report | 2007-01-17 |
| Date Facility Aware | 2006-12-11 |
| Report Date | 2007-01-17 |
| Date Mfgr Received | 2006-12-20 |
| Date Added to Maude | 2007-02-09 |
| 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | FFZ |
| Date Received | 2007-01-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 801137 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-17 |