MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-10 for SYSTEM CORNEO-GAGE II manufactured by Sonogage, Inc..
[16408447]
The radial keratotomy pachometer was malfunctioning when purchased by rptr's facility. The readings were unreliable. It was returned to the mfr to be repaired and arrived still broken. It was used and returned again to be repaired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003643 |
| MDR Report Key | 16700 |
| Date Received | 1994-10-10 |
| Date of Report | 1994-09-22 |
| Date of Event | 1994-08-11 |
| Date Added to Maude | 1994-10-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM CORNEO-GAGE II |
| Generic Name | PACHOMETER |
| Product Code | HJB |
| Date Received | 1994-10-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16633 |
| Manufacturer | SONOGAGE, INC. |
| Manufacturer Address | CLEVELAND OH 44122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-10 |