MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-04-28 for RT-5100 REFRACTOR manufactured by Nidek Co., Ltd.
[15879278]
Nidek (b)(4) performed risk assessment to determine whether the event is mdr reportable. We concluded it would not be a serious injury based on the risk assessment on (b)(4) (27 calendar days). Nidek inc was under fda inspection from (b)(4). We were preparing a correction report to fda and had a opportunity to discuss on our correction strategy with (b)(4). During a teleconference with them on (b)(4), nidek inc was advised by a doctor in (b)(6) that a complaint relating laceration of the nose was a serious injury as follows "i don't think the firms' analysis or strategy is appropriate. I would consider any injury to the face that can cause scarring a serious injury and it is reportable". We determined to submit a mdr to fda based on the advise from (b)(4). We sincerely apologize we did not submit this mdr within 30 calendar days. On the other hand, our correction strategy in the draft of customer notification letter was accepted by all fda attendees in the teleconference on (b)(4). Our strategy is to provide preventive maintenance kit including hex wrench, glue and instruction for use to all customers who purchased rt-5100 or rt-3100. We have already submitted recall report (2936921-4/17/2014-001-c) dated on 04/17/2014 to (b)(4). Pt admitted that they were frustrated with having to wear glasses due to having lasik procedure and enhancement. This is why pt initiated adverse event report.
Patient Sequence No: 1, Text Type: N, H10
[15933328]
Nidek inc received maude event report (b)(4) on (b)(6) 2014 through us distributor, (b)(4). Physician was doing an eye exam. When moving the phoropter, the near point rod fell down and hit the bridge of her nose and she obtained a laceration. Since we could not obtain additional info from our distributor or customers, there is no info indicating that there was a serious injury. However, since we would consider any injury to the face that can cause scarring a serious injury and it is reportable, we determined to submit this mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936921-2014-00002 |
| MDR Report Key | 3808320 |
| Report Source | 00 |
| Date Received | 2014-04-28 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-16 |
| Date Mfgr Received | 2014-02-05 |
| Date Added to Maude | 2014-05-14 |
| 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 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2014-04-28 |
| Model Number | RT-5100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-04-28 |