MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-03 for IPRISM 10820 NA manufactured by Ocular Instruments.
[4483179]
Endophthalmitis in the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014865-2014-00001 |
| MDR Report Key | 3748361 |
| Report Source | 07 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-03-28 |
| Date Added to Maude | 2014-04-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2255 116TH AVE., N.E. |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal | 98004 |
| Manufacturer Phone | 4254555200 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPRISM |
| Generic Name | GONIOPRISM |
| Product Code | HKS |
| Date Received | 2014-04-03 |
| Model Number | 10820 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OCULAR INSTRUMENTS |
| Manufacturer Address | 2255 116TH AVE., N.E. BELLEVUE WA 98004 US 98004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2014-04-03 |