MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2013-01-30 for SURFIT NATURA DURAHESIVE FLAT MOLDABLE WAFER 411804 manufactured by Convatec.
[19728648]
Customer reports his pouch filling half way with blood on (b)(6) 2012, but bleeding resolved once he removed his hernia support belt. He has not worn the hernia support belt since (b)(6) 2012. He changes his skin barrier every 5-7 days. He continues to note blood in his pouch after he changes his skin barrier after it has been in place for 2 days and sometimes on day 3 as well, but then bleeding resolves until he changes his skin barrier again. He said this has occurred every time he has changed his pouch since he first experienced the bleeding in december but the amount of bleeding is less than it was the first time. His pouch fills with approximately. 25 -. 50 inches of blood at the bottom of his pouch before it resolves. He noted this bleeding yesterday but the bleeding has now resolved. No bleeding noted at this time. He is unable to determine the exact location of the bleeding. He suspects the bleeding is coming from various locations around his stoma toward the base because he can see a trail of blood next to his stoma. He has blood work performed every other week when he receives chemotherapy. He said his hemoglobin was 10 last week.
Patient Sequence No: 1, Text Type: D, B5
[19834212]
The adverse event 'bleeding up to half the pouch' is deemed serious as the pt may eventually require a blood transfusion should this go on. From the available info however, it is unlikely that this event is causally related to the use of the device. A more plausible explanation for bleeding of this level of severity would most likely be the presence of abnormal blood vessels around the stoma. The pt has been correctly advised to see his surgeon and oncologist for a better work up. Reported to the fda on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243969-2013-00004 |
| MDR Report Key | 2956413 |
| Report Source | 04,05,06 |
| Date Received | 2013-01-30 |
| Date of Report | 2013-01-16 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2013-01-16 |
| Date Added to Maude | 2013-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATRINA FIELDER |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042541 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURFIT NATURA DURAHESIVE FLAT MOLDABLE WAFER |
| Generic Name | PROTECTOR, OSTOMY |
| Product Code | EZS |
| Date Received | 2013-01-30 |
| Model Number | NA |
| Catalog Number | 411804 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-01-30 |