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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN FEMALE PELVIC HEALTH MESH; SURGICAL MESH
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COLOPLAST A/S UNKNOWN FEMALE PELVIC HEALTH MESH; SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); No Information (3190)
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 or 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 reported, per social media, still having leaks and following surgery, having bowel problems because of fixing the leak.
 
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Brand Name
UNKNOWN FEMALE PELVIC HEALTH MESH
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
lauren prioleau
1601 west river road north
minneapolis, MN 55411
6122196218
MDR Report Key9351348
MDR Text Key167312675
Report Number2125050-2019-00964
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2019
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 Number1
Patient Outcome(s) Other;
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