MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-17 for AVALIGN L-0130 manufactured by Avalign German Specialty Instruments.
| Report Number | 1421101-2019-00001 |
| MDR Report Key | 8705999 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-17 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-05-17 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2019-06-17 |
| 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 | JENNIFER STAUNTON |
| Manufacturer Street | 626 COOPER CT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal | 60173 |
| Manufacturer Phone | 8479080292 |
| Manufacturer G1 | AVALIGN GERMAN SPECIALTY INSTRUMENTS |
| Manufacturer Street | 626 COOPER CT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVALIGN |
| Generic Name | MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10") |
| Product Code | HAE |
| Date Received | 2019-06-17 |
| Catalog Number | L-0130 |
| Lot Number | 120406 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVALIGN GERMAN SPECIALTY INSTRUMENTS |
| Manufacturer Address | 626 COOPER CT SCHAUMBURG IL 60173 US 60173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-17 |