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U.S. Department of Health and Human Services

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

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COLOPLAST A/S SENSURA STD.W/EAR 60MM 10-55MM; OSTOMY COLLECTOR Back to Search Results
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.
 
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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 Key5324364
MDR Text Key34277312
Report Number9610694-2015-00003
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Number of Events Reported1
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 Date10/11/2018
Device Model Number1003101004
Device Catalogue Number1003101004
Device Lot Number4843521
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2015
Initial Date FDA Received12/23/2015
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 Number1
Patient Outcome(s) Other;
Patient Age70 YR
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