MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for AQUILEX FLUID CONTROL SYSTEM AQL-100S AQL-100CBS manufactured by W.o.m. World Of Medicine Gmbh.
| Report Number | 3002914049-2019-00006 |
| MDR Report Key | 8690337 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-11 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2019-06-12 |
| 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 | DR. S MARKWORTH |
| Manufacturer Street | SALZUFER 8 |
| Manufacturer City | BERLIN, 10587 |
| Manufacturer Country | GM |
| Manufacturer Postal | 10587 |
| Manufacturer G1 | W.O.M. WORLD OF MEDICINE GMBH |
| Manufacturer Street | ALTE POSTSTRASSE 11 |
| Manufacturer City | LUDWIGSSTADT, 96337 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 96337 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AQUILEX FLUID CONTROL SYSTEM AQL-100S |
| Generic Name | HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM |
| Product Code | HIG |
| Date Received | 2019-06-12 |
| Returned To Mfg | 2018-10-29 |
| Model Number | AQL-100CBS |
| Catalog Number | AQL-100CBS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M. WORLD OF MEDICINE GMBH |
| Manufacturer Address | SALZUFER 8 BERLIN, 10587 GM 10587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-12 |