MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS® RETROPUBIC SLING SYSTEM; SURGICAL MESH

Model Number 5195612400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Fever (1858); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discomfort (2330); Deformity/ Disfigurement (2360); Fungal Infection (2419); Abdominal Distention (2601); Dysuria (2684); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)

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.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced severe pain with daily activities and intercourse, urinary incontinence, physical deformity and loss of the ability to perform sexually.

Event Description

Additional information received further reported that between (b)(6) 2019 and (b)(6) 2020 the patient was experiencing or had experienced urinary retention for which she was discharged home with a foley catheter, abdominal pain, fever, lower back pain radiating to the groin, numbness to anterior thighs, urinary tract infection (uti), dysuria, bloating, yellow vaginal discharge, epigastric and periumbilical pain, urinary frequency, irritative bladder symptoms, lower abdominal and suprapubic pain with radiating pain to the mid/upper abdomen, malodorous urine, sharp pain with dysuria, pelvic discomfort, sharp stabbing pain to outside of vagina, candidiasis, increase in urinary urgency and frequency.On the following dates, the patient had experienced or was experiencing: on (b)(6) 2019 suspected uti.On (b)(6) 2020 uti with dysuria.On (b)(6) 2020 recurrent bacterial vaginosis and utis.On (b)(6) 2020 suprapubic pain and abdominal distention.On (b)(6) 2020 recurrent uti, dysuria, vaginal discharge, pelvic and perineal pain.

Manufacturer Narrative

D4 lot number: 6564171.

• Brand Name: SUPRIS® RETROPUBIC SLING SYSTEM
• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12291297
• MDR Text Key: 265580857
• Report Number: 2125050-2021-01105
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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: Health Professional
• Device Model Number: 5195612400
• Device Catalogue Number: 519561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female