MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-10-15 for NATURAD/HESIVEMLDW/INVISI POKIT45MM 416917 manufactured by Convatec Inc..
[28437061]
(b)(4). Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[28437062]
Reports that had surgery 1 week ago and has been using same product all week and tuesday noted that purple colored deep red areas from edge of stoma to one quarter out on bottom half of stoma. States home health nurse removed appliance and placed new one same ref number on patient. States it is towards 5 o'clock. Home care rn managing end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2015-30567 |
| MDR Report Key | 5153787 |
| Report Source | OTHER |
| Date Received | 2015-10-15 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2014-03-04 |
| Date Added to Maude | 2015-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAD/HESIVEMLDW/INVISI POKIT45MM |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2015-10-15 |
| Model Number | 416917 |
| Lot Number | 4B03191 |
| Device Expiration Date | 2019-03-03 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-15 |