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 |