MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2019-07-23 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE 98430 991098430 manufactured by Avanos Medical Inc..
| Report Number | 9611594-2019-00143 |
| MDR Report Key | 8815523 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2019-07-23 |
| Date of Report | 2019-09-11 |
| Date Mfgr Received | 2019-08-26 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-07-23 |
| 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 | 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 | INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE |
| Generic Name | DH EF PERC PLACEMENT PRODUCTS |
| Product Code | KGC |
| Date Received | 2019-07-23 |
| Returned To Mfg | 2019-08-01 |
| Model Number | 98430 |
| Catalog Number | 991098430 |
| Lot Number | AA8239R12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-07-23 |