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

Model Number 404593

Device Problem Leak/Splash (1354)

Patient Problems Unspecified Infection (1930); Local Reaction (2035); Skin Erosion (2075)

Event Type  Injury  

Event Description

It was reported that end user had a wound and possible infection near stoma from consistent leakage of wafers since hospitalization.She further informed that she has a doctor's appointment in 2 days.On (b)(6)2015, spoke with end user regarding doctor's appointment, and she described peristomal skin breakdown and stated that her primary care physician, prescribed doxy-cycl hycl 100mg and clotrimazole ups 1%.On (b)(6) 2015, end user had an appointment with her wound doctor on (b)(6) 2015 and he diagnosed her with an allergy to the tape collar.Treatment included using a wafer without tape.End user reported skin has been improving since using the tapeless wafer.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No add'l pt/user 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, assoc, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4890773
• MDR Text Key: 6541380
• Report Number: 1049092-2015-00371
• 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: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• 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: 06/23/2015
• 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 Outcome(s): Required Intervention