MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for GASTROENTEROLOGY-PAED FEEDING 12024182 manufactured by Unomedical S.r.o..
[120137687]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120137688]
It was reported that there was "brown blemish shown in the tip of the connector. " it was further reported that the feeding tube package was not opened and not used. Photographs depicting the reported issue were provided. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2018-00023 |
| MDR Report Key | 7866050 |
| Date Received | 2018-09-11 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-09-11 |
| 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. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | UNOMEDICAL S.R.O. |
| Manufacturer Street | PRIEMYSELNY PARK 3, |
| Manufacturer City | MICHALOVCE 07101 |
| Manufacturer Country | LO |
| Manufacturer Postal Code | 07101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GASTROENTEROLOGY-PAED FEEDING |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-09-11 |
| Model Number | 12024182 |
| Lot Number | 6M02060 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3, MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |