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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S MIO 1P LIGHT URO MX TRP10-23 COLLECTOR, OSTOMY

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COLOPLAST A/S MIO 1P LIGHT URO MX TRP10-23 COLLECTOR, OSTOMY Back to Search Results
Model Number 1683501400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104)
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 available information, the patient was using 16837 since (b)(6) 2017. The hospital switched them to 16835 in (b)(6) 2019. The patient stated that ever since jan 1st. The skin became raw and an infection on the stoma occurred. A lot number was not available. The patient has been in the hospital since friday (b)(6) 2019. Stoma was black and green. The hospital is giving her antibiotics. They switched to 16837 and cut it in oval shape and it seems to be doing better.
 
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Brand NameMIO 1P LIGHT URO MX TRP10-23
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, region hovedstaden 3050
DA 3050
Manufacturer (Section G)
COLOPLAST HUNGARY KFT TATABANYA
buzavirag ut 15
komarom-esztergom
tatabanya, 2800
HU 2800
Manufacturer Contact
mike bumgarner
1601 west river road n
minneapolis, MN 55411
6122630488
MDR Report Key8582989
MDR Text Key144167709
Report Number3003814961-2019-00001
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1683501400
Device Catalogue Number1683501400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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