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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SURGICAL MESH

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COLOPLAST A/S SURGICAL MESH Back to Search Results
Model Number FPH-MESH-UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Tract Infection (2120); Ambulation Difficulties (2544)
Event Date 06/10/2011
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. However, because examination of the returned components may not conclusively confirm or disprove the report of pain, quality accepts the physician¿s observations of such as the reason for surgical intervention. As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
 
Event Description
According to the available information the mesh was implanted on (b)(6) 2009 and there was a report of pain and urinary tract infection.
 
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Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12450587
MDR Text Key270765607
Report Number2125050-2021-01283
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 foreign
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFPH-MESH-UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
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