MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-11-30 for ALLEGRO TOPOLYZER VARIO 8065990710 manufactured by Wavelight Gmbh.
[3045371]
A surgeon reported that the measurements of one pt were associated with the name of another pt. The measurements were not used to develop any treatments, and there was no harm to any pt.
Patient Sequence No: 1, Text Type: D, B5
[10262751]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in according with 21 cfr 803. 56 when additional reportable info becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003288808-2012-00494 |
| MDR Report Key | 2854755 |
| Report Source | 01,05 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-01 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2012-11-01 |
| Date Added to Maude | 2013-03-07 |
| 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 | PAUL NITSCHMANN |
| Manufacturer Street | 6201 S. FREEWAY R3-16 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | WAVELIGHT GMBH |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEGRO TOPOLYZER VARIO |
| Generic Name | CORNEAL TOPOGRAPHY SYSTEM |
| Product Code | MMQ |
| Date Received | 2012-11-30 |
| Model Number | 8065990710 |
| Catalog Number | 8065990710 |
| Lot Number | NA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH |
| Manufacturer Address | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-30 |