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

Model Number 5196502400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, between (b)(6) 2018- (b)(6) 2020: recurrent utis; vaginal odor and pain; pain in buttocks, low back and hips, urinalysis showed trace bacteria, groin pain, lower abdominal pain, recurrent utis, vaginitis.On (b)(6) 2018 removal of altis mesh under general anesthesia.Right flank and bilateral upper leg pain, urinary incontinence, right hip pain, back pain with radiation, abnormal urine odor, pelvic pain, rlq pain, right hip pain, urinary incontinence, uti, muscle spasm, chronic pelvic pain.No other adverse patient effects were reported.

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.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13011716
• MDR Text Key: 285338159
• Report Number: 2125050-2021-01782
• 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: 12/15/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4933380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2021
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female