MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-02 for RT-5100 manufactured by Nidek Co., Ltd.
[76630289]
No serious injury occurred and no known impact or consequence to the doctor involved. However, nidek considers it a reportable event as the device had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Nidek hired third party ((b)(4)) to perform the correction as per recall (z-1245-2016). At this time, device evaluation anticipated but has not begun. Therefore, a follow-up will be submitted once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[76630290]
On may 19, 2017, during a recall process, nidek inc. Recall coordinator received information from a doctor that the near point rod of rt-5100 serial #(b)(4) had fallen multiple times and hit him in the nose. Doctor felt horrible pain and compared it to being punched in the face. However, the doctor stated that medical treatment was unnecessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00008 |
| MDR Report Key | 6609088 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-19 |
| Device Manufacturer Date | 2011-07-05 |
| Date Added to Maude | 2017-06-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PREETI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5102265750 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1245-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2017-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-02 |