MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-06 for RT-5100 manufactured by Nidek Co., Ltd..
[20073031]
Nidek received a complaint from the customer on (b)(6) 2015. Customer reported that during the use of rt-5100 sn (b)(4), the near point chart arm fell down and hit the doctor on the face. Nidek also confirmed that the doctor did sustain a bruise on his head near the eye due to the rod.
Patient Sequence No: 1, Text Type: D, B5
[20257186]
The affected device was not returned to nidek for evaluation. The device has not been evaluated yet. However, a service engineer would conduct an on-site evaluation and perform the preventive maintenance according to the recall procedure. Nidek contacted the customer to verify the complaint about the injury and confirmed that the injury was minor, it was a small bruise. No medical or surgical intervention was required for the injury. If additional significant information is received at a later date after the evaluation, a follow-up report will be submitted. Nidek inc. Considers it a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00001 |
| MDR Report Key | 4512499 |
| Report Source | 05,06 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2015-01-08 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2015-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREEMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5103537785 |
| 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-1853-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2015-02-06 |
| 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, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |