MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-06 for GRIESHABER 149.52 * manufactured by Grieshaber & Co.
[15488688]
Silicone tip came off 20 ga soft tip needle intraocularly. Retrieved without problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011412 |
| MDR Report Key | 96436 |
| Date Received | 1997-06-06 |
| Date of Report | 1997-05-28 |
| Date of Event | 1997-05-20 |
| Date Added to Maude | 1997-06-10 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIESHABER |
| Generic Name | INTRAOCULAR SOFT TIP NEEDLE |
| Product Code | HNM |
| Date Received | 1997-06-06 |
| Returned To Mfg | 1997-05-28 |
| Model Number | 149.52 |
| Catalog Number | * |
| Lot Number | 151CG7 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 95208 |
| Manufacturer | GRIESHABER & CO |
| Manufacturer Address | 1945 VAUGHN RD. KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-06 |