MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-09-11 for WAVICIDE - 01 * manufactured by Medical Chemical Corp..
[109182]
While disposing of a used needle, pt accidentally got some wavicide -01 in her eyes. Pt wasn't wearing safety glasses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247256-1998-00053 |
| MDR Report Key | 187683 |
| Report Source | 00 |
| Date Received | 1998-09-11 |
| Date Added to Maude | 1998-09-21 |
| 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 |
| Reporter Occupation | PHLEBOTOMIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVICIDE - 01 |
| Generic Name | * |
| Product Code | LFE |
| Date Received | 1998-09-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 02-80602 |
| ID Number | * |
| Device Expiration Date | 1999-06-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 182416 |
| Manufacturer | MEDICAL CHEMICAL CORP. |
| Manufacturer Address | 25 MANSARD CT. WAYNE NJ 07470 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-11 |