MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-02 for SEIBEL CHOPPER manufactured by Rhein Medical Inc..
[3828780]
The patient was undergoing a cataract surgery, when the seibel chopper tip broke off in the patient's eye. The surgeon retrieved the broken piece out of the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031314 |
| MDR Report Key | 3272590 |
| Date Received | 2013-08-02 |
| Date of Report | 2013-08-02 |
| Date of Event | 2013-07-22 |
| Date Added to Maude | 2013-08-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SEIBEL CHOPPER |
| Product Code | HNQ |
| Date Received | 2013-08-02 |
| Lot Number | 14562 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RHEIN MEDICAL INC. |
| Manufacturer Address | 5460 BEAUMONT CENTER BLVD. STE. 500 TAMPA FL 33634 US 33634 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-02 |