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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH; SURGICAL MESH
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COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH; SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Burning Sensation (2146); Urinary Frequency (2275); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast, though not verified patient's legal representative stated frequent urination, incontinence of urine, dribbling of her urine, chronic pain shooting down her left leg, burning type numbness.It follows her buttocks down through her gastrocnemius and along the sole of her foot.Upon mri, it looks like a large bone spur and possibly a recurrent disk herniation.Three months of physical therapy, used a tens unit, chiropractic care, and epidural steroid injection.Plans on receiving an epidural steroid injection for the pain.
 
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Brand Name
UNKNOWN FEM PELVIC HEALTH MESH
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6308719
MDR Text Key66723166
Report Number2125050-2017-00007
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
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