MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-09-26 for ENTERAL ACCESS DILATION SYSTEM 98703 109870301 manufactured by Avanos Medical Inc..
| Report Number | 9611594-2019-00181 |
| MDR Report Key | 9126463 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2019-09-26 |
| Date of Report | 2019-11-04 |
| Date Mfgr Received | 2019-10-09 |
| Date Added to Maude | 2019-09-26 |
| 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 | RISK MANAGER |
| 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 SA DE R.L. DE C.V. (AVENT 1) |
| Manufacturer Street | CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA |
| Manufacturer City | NOGALES, CP |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERAL ACCESS DILATION SYSTEM |
| Generic Name | DH EF PERC PLACEMENT PRODUCTS |
| Product Code | KGC |
| Date Received | 2019-09-26 |
| Model Number | 98703 |
| Catalog Number | 109870301 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-09-26 |