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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH

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COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
Model Number 5014502400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fever (1858); Inflammation (1932); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Vomiting (2144); Hematuria (2558)
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 following were noted in (b)(6) 2013: flank pain with radiation to the abdomen, hematuria and recurrent urinary tract infections (uti), right flank pain with hydronephrosis, nausea, recurrent cystitis, and microhematuria. It was also noted: cystoscopy, retrogrades, right ureteral dilation with balloon and placement of stent under general anesthesia. On (b)(6), 2013, it was noted the patient visited the emergency room for nausea, vomiting, and abdominal pain. She was diagnosed with a uti in the ed. She had been treated for uti with pcp two days prior. The patient had a stent placed for kidney stones several years prior to 2013, but ¿never followed through. ¿ she presented to the emergency room with a uti, severe right-sided flank pain, nausea, vomiting, and a temperature. Two & three days later, the patient was experiencing intractable nausea, vomiting, and abdominal pain. Recurrent utis with nephrolithiasis. Significant pain in the flank area. Laser lithotripsy of the stent stone and ureteral stone, retrograde stent removal and placement of new stent under general anesthesia.

 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
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
usauv autumn valentine
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11695714
MDR Text Key246777227
Report Number2125050-2021-00397
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Type of Report Initial
Report Date 04/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number5014502400
Device Catalogue Number501450
Device LOT Number3008778
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/08/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/20/2021 Patient Sequence Number: 1
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