MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-11 for PRESERVATION MEDIUM manufactured by .
[4241864]
(b)(6) for transplant, received a faxed (b)(6) adverse reaction report on (b)(6) 2006 from dr (b)(6) for recipient (b)(6). Culture report: specimen source: swab cornea, donor medium. Result: it propioni bacterium acnes. Dr (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034886 |
| MDR Report Key | 3675292 |
| Date Received | 2014-03-11 |
| Date of Report | 2006-09-22 |
| Date of Event | 2006-08-29 |
| Date Added to Maude | 2014-03-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PRESERVATION MEDIUM |
| Product Code | LYX |
| Date Received | 2014-03-11 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-11 |