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 2020-03-18 for MEDISORB? EF MULTI-ABSORBER, DISPOSABLE M1173311 manufactured by Vyaire Medical.
| Report Number | 3002807637-2020-00002 |
| MDR Report Key | 9849713 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | MOLECULAR PRODUCTS LTD |
| Manufacturer Street | PARKWAY HARLOW BUSINESS PARK HARLOW ESSEX, UK CM19 5FR |
| Manufacturer City | HARLOW, ESSEX, CM195FR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM19 5FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDISORB? EF MULTI-ABSORBER, DISPOSABLE |
| Generic Name | CO2 ABSORBERS |
| Product Code | CBL |
| Date Received | 2020-03-18 |
| Model Number | MEDISORB? EF MULTI-ABSORBER, DISPOSABLE |
| Catalog Number | M1173311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |