MAUDE Adverse Event Report: COLOPLAST A/S SENSURA STD.W/EAR 60MM 10-55MM; OSTOMY COLLECTOR

Model Number 1003101004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence, should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported though not verified, the patients skin still showing strong skin irritation.This consumer got a colostoma on (b)(6) 2015, since than he has used the base plate together with brava paste and brava barrier spray.His skin has shown strong redness, which is weeping, itching and aching located in the area of the base plate.The patient has consulted a physician who has done an allergie-test, which has shown the patient is allergic to 1,3-diphenylguanidine.Furthermore a small wound, which is producing yellow-green secretion, existing beside the stoma.The physician has prescribed cortisone salve to treat the skin irritation.The skin became better, redness still existing, but not weeping and new epithelial tissue has grown in places.

• Brand Name: SENSURA STD.W/EAR 60MM 10-55MM
• Type of Device: OSTOMY COLLECTOR
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5324364
• MDR Text Key: 34277312
• Report Number: 9610694-2015-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2018
• Device Model Number: 1003101004
• Device Catalogue Number: 1003101004
• Device Lot Number: 4843521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR