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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR; SURGICAL MESH
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COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR; SURGICAL MESH Back to Search Results
Model Number 5014601022
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 02/10/2010
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 perineal pain, pain with sitting, exposure of mesh; painful rectocele, probable infected mesh of the rectovaginal spectrum, enterocele and cystocele.
 
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Brand Name
RESTORELLE DIRECTFIX POSTERIOR
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 Key5777242
MDR Text Key49027423
Report Number2125050-2016-00067
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number5014601022
Device Catalogue Number5014601022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/17/2016
Initial Date FDA Received07/07/2016
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
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