MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 1999-05-10 for 20X WASH BUFFER CONCENTRATE 933730 manufactured by Ortho-clinical Diagnostics, Inc..
[16267442]
Technician accidentally spilled prepared wash buffer from an overhead countertop and inadvertently ingested a sip. Poison control and medical physician contacted.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2250051-1999-00047 |
MDR Report Key | 222994 |
Report Source | 00,05 |
Date Received | 1999-05-10 |
Date of Report | 1999-04-06 |
Date of Event | 1999-04-06 |
Date Mfgr Received | 1999-04-06 |
Device Manufacturer Date | 1998-09-01 |
Date Added to Maude | 1999-05-17 |
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 | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 20X WASH BUFFER CONCENTRATE |
Generic Name | WASH BUFFER |
Product Code | IFP |
Date Received | 1999-05-10 |
Model Number | NA |
Catalog Number | 933730 |
Lot Number | CHL322-2 |
ID Number | NA |
Device Expiration Date | 1999-09-15 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | NA |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 216257 |
Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
Manufacturer Address | 1001 US HWY 202 RARITAN NJ 08869 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1999-05-10 |