MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-15 for A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX NA manufactured by Applied Medical Resources.
Report Number | 2027111-2019-00634 |
MDR Report Key | 9330555 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2019-11-15 |
Date of Report | 2019-11-15 |
Date Mfgr Received | 2019-11-14 |
Date Added to Maude | 2019-11-15 |
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 | WENDY KOBAYASHI |
Manufacturer Street | 22872 AVENIDA EMPRESA |
Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
Manufacturer Country | US |
Manufacturer Postal | 92688 |
Manufacturer Phone | 9497138059 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NI |
Event Type | 3 |
Type of Report | 3 |
Brand Name | A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX |
Generic Name | CLIP, VASCULAR |
Product Code | DSS |
Date Received | 2019-11-15 |
Model Number | A1603 |
Catalog Number | NA |
Lot Number | NA |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | APPLIED MEDICAL RESOURCES |
Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-15 |