MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-06-10 for RT-5100 REFRACTOR manufactured by Nidek Co., Ltd..
[18001423]
Nidek inc. Received a complaint from a customer on (b)(6) 2014 through us 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 her physician. The required medical treatment is unknown. Optometrist was able to return to work that same day. She required no further treatment. Specific information regarding the individual that was injured is not being disclosed to (b)(4). Since the information received indicates a potential risk of serious injury, nidek inc. And nidek co. , ltd. (b)(4) determined to submit each mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2014-00003 |
| MDR Report Key | 4001942 |
| Report Source | 06,08 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-05-10 |
| Date Mfgr Received | 2013-05-12 |
| Date Added to Maude | 2014-08-26 |
| 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 | 47651 WESTINGHOUSE DR. |
| Manufacturer City | FREEMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5102265700 |
| Manufacturer G1 | NIDEK CO., LTD. HAMACHO PLANT |
| Manufacturer Street | 34-14 MAEHAMA HIROSHI-CHO |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-4/17/2014-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 REFRACTOR |
| Generic Name | NONE |
| Product Code | HKN |
| Date Received | 2014-06-10 |
| 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 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-10 |