MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-13 for AIRSEAL INSUFFLATION UNIT AS-IFS 2 manufactured by W.o.m World Of Medicine Gmbh.
| Report Number | 3006217371-2019-00396 |
| MDR Report Key | 9315476 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-11-10 |
| Date Mfgr Received | 2019-11-11 |
| Date Added to Maude | 2019-11-13 |
| 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 | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Street | SALZUFER 8 4TH FLOOR |
| Manufacturer City | BERLIN, 10587 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 10587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRSEAL INSUFFLATION UNIT |
| Generic Name | INSUFFLATION UNIT |
| Product Code | HIF |
| Date Received | 2019-11-13 |
| Catalog Number | AS-IFS 2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Address | SALZUFER 8 4TH FLOOR BERLIN, 10587 GM 10587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-13 |