MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; INFLATABLE PENILE PROSTHESIS

Model Number 5196502400

Device Problems Fracture (1260); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868); Micturition Urgency (1871); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency (2275); Sleep Dysfunction (2517); Fibrosis (3167); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, between 10/2017-9/4/2018: uti, bladder pain, urinary hesitancy, vaginal itching, urinary frequency, urine culture showed >100,000 cfu/ml escherichia coli and 25-50,000 cfu/ml mixed gram positive/gram negative flora, pelvic and flank pain, pelvic floor dysfunction, bladder spasms, impaired sleep, urethral pain, urine culture showed 25-50,000 cfu/ml klebsiella pneumoniae, urinary incontinence, postoperative hemorrhage of vagina following genitourinary procedure, pelvic floor dysfunction, vaginal pain, mid to lower back pain, scar tissue, moderate detrusor instability, intrinsic sphincteric deficiency, cutting sensation in vagina and near urethra, nocturia, urinary urgency, urine culture showed >100,000 cfu/ml escherichia coli.Ua showed 1+ blood and leukocyte esterase, 12 wbc and + bacteria.On (b)(6) 2018 altis sling removal, urethral lysis, anterior colporrhaphy, vaginal paravaginal, removal of mesh from obturator internus muscles, removal of exposed ethibond from the posterior vaginal wall and gortex from the vaginal apex, and release of vaginal septum under general anesthesia for vaginal pain, urethral pain, pain with intercourse, foreign material in vagina and in pelvic muscles, scarring, rectocele, and cystocele.Pathology showed fibrosis, chronic inflammation, and foreign body giant cell reaction surrounding polarizable foreign material, compatible with mesh.Old tissue discharge, needle poking pain in vagina, pelvic derangement, pressure in vagina, pelvic floor weakness.No other adverse patient effects were reported.

Event Description

Additional information received further reported that trigger point injections calmed the patient's vaginal pain.The altis was rolled and twisted left of midline.The altis was excised; however, the anchor fractured and was not able to be removed.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• 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: 13014333
• MDR Text Key: 287394001
• Report Number: 2125050-2021-01785
• 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,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5449719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female