MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-21 for BAXTER DIAGNOSTICS * 4320-90B manufactured by Richard-allen Scientific.
[15259236]
Employee in distribution lifted box to shoulder and felt wetness; on checking box of formalin, identified # of 90cc containers leaking. On further exam, second employee exposed on hands. First employee changed shirt and cleaned shoulder; second employee washed hands.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 128212 |
| MDR Report Key | 128212 |
| Date Received | 1997-10-21 |
| Date of Report | 1997-10-09 |
| Date of Event | 1997-09-22 |
| Date Facility Aware | 1997-09-22 |
| Report Date | 1997-10-09 |
| Date Reported to Mfgr | 1997-10-09 |
| Date Added to Maude | 1997-10-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAXTER DIAGNOSTICS |
| Generic Name | S/P PRE-FILLED BUFFERED 10% FORMALIN |
| Product Code | IFP |
| Date Received | 1997-10-21 |
| Model Number | * |
| Catalog Number | 4320-90B |
| Lot Number | 97H26 |
| ID Number | * |
| Device Expiration Date | 1999-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 125446 |
| Manufacturer | RICHARD-ALLEN SCIENTIFIC |
| Manufacturer Address | 225 PARSONS ST. KALAMAZOO MI 49007 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-21 |