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 2019-11-22 for PARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA 61450 109279402 manufactured by Avanos Medical Inc..
| Report Number | 3006646024-2019-00027 |
| MDR Report Key | 9363153 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-11-01 |
| Device Manufacturer Date | 2019-08-16 |
| Date Added to Maude | 2019-11-22 |
| 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. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT, INC. |
| Manufacturer Street | 6620 S. MEMORIAL PLACE, SUITE 100 |
| Manufacturer City | TUCSON AZ 85756 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA |
| Generic Name | DH ENDOSCOPY PARACENTESIS PRODUCTS |
| Product Code | LRQ |
| Date Received | 2019-11-22 |
| Model Number | 61450 |
| Catalog Number | 109279402 |
| Lot Number | 0203260156 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-22 |