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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN SURGICAL MESH

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COLOPLAST A/S UNKNOWN SURGICAL MESH Back to Search Results
Model Number FPH-MESH-UNKNOWN
Device Problem Expulsion (2933)
Patient Problems Bacterial Infection (1735); Erosion (1750); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report. 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. (b)(4).
 
Event Description
As reported to coloplast, though not verified, a follow up visit on (b)(6) 2015 noted the patient was completely dry. The patient noted on (b)(6) 2017 that she had felt some stitching or tape in the vaginal region, discomfort during intercourse, return of frequency and some leakage for the previous three months. Upon examination ¿palpable tape near superior vault vagina difficult to visualise with speculum. ¿ at an examination on (b)(6) 2018, the patient stated she noticed a return of her stress urinary incontinence symptoms, leakage with cough, sneeze and with intercourse, worse than previously. The patient also noted extrusion. She has had recurrent episodes of bacterial vaginosis, which although respond to antibiotics, recur approximately every 6-8 weeks. The patient had dyspareunia and her husband was able to feel the previous tape on intercourse. The patient had no visible haematuria or urinary tract infections. The patient denied any urgency type symptoms. Upon vaginal examination with a speculum there was a small area of erosion, which was both palpable and visible, approximately 1. 5 cm from the introitus. On (b)(6) 2018 there was a surgery to excise the extruded transobturator tape (tot). On (b)(6) 2018 physician indicated that after revision of the tot on (b)(6) 2018 the patient stated her discomfort dyspareunia improved, but now the patient has ongoing and worse stress urinary incontinence, particularly on intercourse. On examination, the patient had evidence of urethral hypermobility and leak with cough. The physician could not feel any further palpable tape. The patient showed evidence of type 2b stress urinary incontinence. The patient was unable to void standing but emptied her bladder to completion. The patient underwent a colposuspension procedure completed on (b)(6) 2019.
 
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Brand NameUNKNOWN
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 Key11315869
MDR Text Key238869275
Report Number2125050-2021-00126
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
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 Received01/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/11/2021 Patient Sequence Number: 1
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