MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-15 for EAKIN FISTULA & WOUND POUCH 4.3 X 3.0 839251 manufactured by Convatec Inc..
[42851518]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No lot number or product evaluation sample is available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42851519]
It was reported by a nurse that after the pouch was applied and worn for 24 hours by the end user, some of the eakin barrier remained on the skin and was difficult to remove when the nurse was attempting to remove the pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2016-00162 |
| MDR Report Key | 5583160 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-15 |
| Date of Report | 2016-03-25 |
| Date of Event | 2016-03-25 |
| Date Mfgr Received | 2016-03-25 |
| Date Added to Maude | 2016-04-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAKIN FISTULA & WOUND POUCH 4.3 X 3.0 |
| Generic Name | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY |
| Product Code | FON |
| Date Received | 2016-04-15 |
| Model Number | 839251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-15 |