MAUDE Adverse Event Report: CONVATEC INC NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 404593

Device Problem Off-Label Use (1494)

Patient Problem Blood Loss (2597)

Event Date 12/31/2014

Event Type  Injury  

Event Description

The end user reported intermittent bleeding to his stoma.He stated that he accidently touched the stoma with the cut piece of wafer which caused the bleeding.He further reported that the area has completely healed.It was noted that his wafer was designed to be molded but, he was cutting wafer.We has instructed in use of product.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No add'l pt/event details have been provided to date.Should add'l info become available a f/u report will be submitted.

• Brand Name: NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interm assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4612097
• MDR Text Key: 5660854
• Report Number: 1049092-2015-00152
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR