MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-04 for BACKFLUSH HANDLE DSP 337.88 manufactured by Alcon Grieshaber Ag.
| Report Number | 3003398873-2019-00042 |
| MDR Report Key | 8666005 |
| Date Received | 2019-06-04 |
| Date of Report | 2019-10-10 |
| Date Mfgr Received | 2019-09-26 |
| Date Added to Maude | 2019-06-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACKFLUSH HANDLE DSP |
| Generic Name | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, ACCESSORY |
| Product Code | HQE |
| Date Received | 2019-06-04 |
| Model Number | NA |
| Catalog Number | 337.88 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-04 |