MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for HANKS BALANCED SALT SOLUTION manufactured by Corning Cellgro/mediatech.
[71888945]
Rare fungus seen on pathology results for 4 patients cryptococcus adeliensis. Literature search revealed that this fungus can be seen as contaminant in hanks solution which was used in all 4 biopsies. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068887 |
| MDR Report Key | 6459750 |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-01-06 |
| Date Added to Maude | 2017-04-05 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HANKS BALANCED SALT SOLUTION |
| Generic Name | HANKS BALANCED SALT SOLUTION |
| Product Code | KIP |
| Date Received | 2017-04-04 |
| Lot Number | 23315002 |
| Device Expiration Date | 2018-10-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORNING CELLGRO/MEDIATECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-04 |