MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-28 for FULL AUTO REF-KERATOMETER RK-F2 6937B002AA manufactured by Canon, Inc..
[3154155]
The customer reported that they were getting inaccurate readings when using the device.
Patient Sequence No: 1, Text Type: D, B5
[10369573]
(b)(4). Investigation is still in-progress. If additional information is received regarding the investigation, a supplemental report will be submitted per 21 cfr 803. 56. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000181430-2012-00081 |
| MDR Report Key | 2941774 |
| Report Source | 06 |
| Date Received | 2012-12-28 |
| Date of Report | 2012-10-16 |
| Date Mfgr Received | 2012-10-16 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-03-26 |
| 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 Contact | MR. NAOYASU ASAKA, MANAGER |
| Manufacturer Street | 30-2 SHIMOMARUKO, 3-CHOME OHTA-KU |
| Manufacturer City | TOKYO 146-8501 |
| Manufacturer Country | JA |
| Manufacturer Postal | 146-8501 |
| Manufacturer Phone | 37582111 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FULL AUTO REF-KERATOMETER RK-F2 |
| Product Code | HKO |
| Date Received | 2012-12-28 |
| Model Number | RK-F2 |
| Catalog Number | 6937B002AA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CANON, INC. |
| Manufacturer Address | 30-2 SHIMOMARUKO, 3-CHOME OHTA-KU TOKYO 146-8501 JA 146-8501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-28 |