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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S 1PC URO MAXI TRAN 10/55MM TERA UROSTOMY BAG

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COLOPLAST A/S 1PC URO MAXI TRAN 10/55MM TERA UROSTOMY BAG Back to Search Results
Model Number 1247401400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Post Operative Wound Infection (2446)
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
According to the information received, the user's wife indicated use of the samples caused skin blistering where the adhesive contacted the skin. These skin blisters "popped" and drained into a nearby surgical incision from a recent ostomy surgery. The incision became infected subsequent to the blisters draining into the wound. The user was now under the doctor's care and receiving antibiotics. The exact nature of the infection nor the specific antibiotic was provided.
 
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Brand Name1PC URO MAXI TRAN 10/55MM TERA
Type of DeviceUROSTOMY BAG
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, DK-30 50
DA DK-3050
Manufacturer (Section G)
COLOPLAST A/S
coloplast hungary kft
buzavirag ut 15
tatabanya, hu 2800
HU 2800
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key5946058
MDR Text Key54555474
Report Number3003814961-2016-00003
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 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1247401400
Device Catalogue Number1247401400
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
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

Patient Treatment Data
Date Received: 09/13/2016 Patient Sequence Number: 1
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