MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Myalgia (2238); Numbness (2415); Neuralgia (4413); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); 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, legal representative stated the patient with this device experienced pelvic pain, device revision, cystoscopy, pelvic pain with voiding, painful sitting and performing other enjoyable activities, pain at the vaginal introitus and lateral on the distal vagina, pelvic pain, vaginal pain that shoots into left groin, unable to have sexual intercourse due to pelvic pain, physical therapy visits for pelvic pain, dyspareunia, hypermobile urethra, nocturia three times, mixed urinary incontinence, obturator nerve pain, pelvic floor pain, pudendal neuralgia, groin pain, overactive bladder, pelvic floor dysfunction, myalgia of pelvic floor, muscle spasm, urge incontinence with voiding every 1-2 hours, takes long time to empty, unable to feel urine coming out, constant sharp deep right vaginal pain, dull left groin, vulvar pain radiating out toward hip and down inner thigh, pain worse with full bladder, sitting less than 20 minutes, standing, bowel movement, full stomach, stress, pain wakes her up at night, slow start, intermittent, trickling despite strong urge, stands up before she is done because she cannot feel if urine is still coming out, feels she has loss sensation internally, more sensitive externally, frequency, pelvic floor dysfunction, and mixed urinary incontinence.Patient had a pudendal nerve block.Patient had a physical exam that noted pain in the sub urethral region extending to the obturator internus.Patient had a partial explantation of the device.Intraoperative findings noted minimal scar tissue at site of device placement.Approximately 2.0 cm of the device was removed on the right and 2.0 cm on the left was removed.Pathology report notes synthetic portions of material consistent with surgical mesh measuring 2 x 1.5 x 0.2 cm.Final diagnosis noted fragments of fibrous tissue with foreign body giant cell reaction.Patient had a physical therapy evaluation for severe pelvic and perineal pain.Pain is at the introitus and lateral on the distal vaginal area along with levator spasm.Pain increases as the day progresses.

• Brand Name: ALTIS SINGLE INCISION 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15886355
• MDR Text Key: 304526377
• Report Number: 2125050-2022-01325
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• 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
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6740818
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2022
• Date Device Manufactured: 06/10/2019
• 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): Required Intervention
• Patient Age: 46 YR