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

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.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Type of Device: SURGICAL 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 Key: 11695714
• MDR Text Key: 246777227
• Report Number: 2125050-2021-00397
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 3008778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Date Device Manufactured: 12/08/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention