MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-17 for ILEOSTOMY CATHETER 68730 manufactured by Wellspect Healthcare, A Division Of Dentsply Ih Ab.
[33762407]
This product was not able to be returned. Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurence. Should the device or additional information be received, a follow up report will be filed. No samples were received.
Patient Sequence No: 1, Text Type: N, H10
[33762408]
According to the reporter the ileostomy catheter is too soft which makes it kink upon usage. The kinked catheter induces pain and bleeding. As a result of the pain and bleeding reported a revision surgery of the stoma will be needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009632672-2015-00014 |
| MDR Report Key | 5306590 |
| Report Source | CONSUMER |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-17 |
| Date Mfgr Received | 2015-11-25 |
| Date Added to Maude | 2015-12-17 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SOFIA HJORTMO |
| Manufacturer Street | AMINOGATAN 1 P.O. BOX 14 |
| Manufacturer City | M 43121 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43121 |
| Manufacturer Phone | 13764000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILEOSTOMY CATHETER |
| Generic Name | CATHETER, RECTAL FOR CONTINENT ILEOSTOMY |
| Product Code | KPH |
| Date Received | 2015-12-17 |
| Model Number | 68730 |
| Catalog Number | 68730 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB |
| Manufacturer Address | AMINOGATAN 1 P.O. BOX 14 M?LNDAL, 43121 SW 43121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-17 |