MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-12 for MSI * 135016-5 manufactured by Msi.
[378992]
Iris retractors inserted temporarily in the eye during cataract surgery. When being removed from the eye the hooks at the end of the device broke off in the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035171 |
| MDR Report Key | 592012 |
| Date Received | 2005-04-12 |
| Date of Report | 2005-04-12 |
| Date of Event | 2005-03-10 |
| Date Added to Maude | 2005-04-19 |
| 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 |
| 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 | MSI |
| Generic Name | DISPOSABLE IRIS RETRACTORS |
| Product Code | HNI |
| Date Received | 2005-04-12 |
| Returned To Mfg | 2005-04-11 |
| Model Number | * |
| Catalog Number | 135016-5 |
| Lot Number | 161238 |
| ID Number | * |
| Device Expiration Date | 2008-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 581865 |
| Manufacturer | MSI |
| Manufacturer Address | * PHOENIXVILLE PA 194602628 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-12 |