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.
[76561398]
No serious injury occurred, the doctor involved had minor bleeding on the head, and stated that medical treatment was unnecessary. However, nidek inc considers it a reportable event as the device had malfunction and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Nidek hired third party (noritsu) 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
[76561399]
On may 15, 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 hit him in the head on multiple occasions. Furthermore, the doctor stated that the near point rod has caused him to bleed and form a little scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00005 |
| MDR Report Key | 6608983 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Device Manufacturer Date | 2011-11-10 |
| 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 |