MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-06-05 for RT-5100 REFRACTOR manufactured by Nidek Co, Ltd.
[15811106]
Nidek inc received a complaint from a customer on (b)(6) 2014 through u. S. Distributor, (b)(4). Rt-5100 near point rod fell down and hit optometrist in her eye area on (b)(6) 2014. The optometrist visited emergency room for medical evaluation and treatment to her eye and was evaluated by a physician. The required medical treatment is unk. Optometrist was able to return to work that same day. She required no further treatment. Specific info regarding the individual that was injured is not being disclosed to (b)(4). Since the info received indicates a potential risk of serious injury, we determined to submit a mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936921-2014-00003 |
| MDR Report Key | 3958128 |
| Report Source | 06,08 |
| Date Received | 2014-06-05 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-10 |
| Date Mfgr Received | 2013-05-12 |
| Date Added to Maude | 2014-08-01 |
| 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 Contact | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DR. |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5102265700 |
| Manufacturer G1 | NIDEK CO, LTD |
| Manufacturer Street | 34-14 MAEHAMA HIROISHI-CHO |
| Manufacturer City | GAMAGORI, AICHI |
| Manufacturer Country | JA |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-04/17/2014-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 REFRACTOR |
| Generic Name | NONE |
| Product Code | HKN |
| Date Received | 2014-06-05 |
| Model Number | RT-5100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO, LTD |
| Manufacturer Address | 34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-05 |