MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-05 for TRYPTIC SOY BROTH, INJECTABLE NI manufactured by Mcgaw, Inc..
[163498]
The problem was observed on 12/28/98. Foreign material noted in the broth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002399 |
| MDR Report Key | 206583 |
| Date Received | 1999-01-05 |
| Date of Report | 1999-01-05 |
| Date of Event | 1998-12-28 |
| Date Added to Maude | 1999-01-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRYPTIC SOY BROTH, INJECTABLE |
| Generic Name | TRYPTIC SOY BROTH, INJECTABLE |
| Product Code | JSC |
| Date Received | 1999-01-05 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 226 |
| ID Number | 20 ML |
| Device Expiration Date | 1999-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 200520 |
| Manufacturer | MCGAW, INC. |
| Manufacturer Address | 2525 MCGAW AVE PO BOX 19791 IRVINE CA 927139791 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-05 |