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

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.

• Brand Name: UNKNOWN
• 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: 11315869
• MDR Text Key: 238869275
• Report Number: 2125050-2021-00126
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FPH-MESH-UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• 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
• Patient Age: 51 YR