MAUDE Adverse Event Report: COLOPLAST CORP ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Anemia (1706); Fatigue (1849); Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Scar Tissue (2060); Swelling (2091); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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, the patient's legal representative stated serious bodily injuries, including but not limited to, foreign body reaction, right lower quadrant pain, pelvic pain, dyspareunia, incontinence and other injuries.

Manufacturer Narrative

This follow-up mdr is created to document the additional patient dob, lot number, and explant date.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

This follow up mdr is created to document the additional event information and correction/addition of h6 codes.Patient code 3191 was selected because the appropriate code was not available for "clotting", "pulling sensation" coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information, reported to coloplast though not verified, indicated post-operative bleeding and clotting, reinforcement of vaginal cuff and repair of left vaginal puncture under general anesthesia, pulling sensation on left side, low hemoglobin, pain and redness site, midurethral swelling with build-up of scar tissue at midline over the sling, urinary loss of control/incontinence, significant lower abdominal pain, worsened incontinence, dyspareunia, hematuria.(b)(6) 2018 - laparoscopy with lysis of adhesions, right salpingo-oophorectomy excision of altis suburethral sling, cystourethroscopy under general anesthesia.(b)(6) 2018 urine leakage with movement.

Event Description

Additional information received reported that, upon return to the operating room, a vaginal puncture site was discovered, which had occurred during the initial surgical attempt at altis placement.The patient experienced pain localized to point of fascial closure of left trocar site, fatigue, rolled mesh, and nocturia.Several periurethral bulking injections between 26jun2018 and 08jul2019.On (b)(6) 2019 cystourethroscopy and periurethral bulking injections took place.Intraoperative findings included urethrocele visible at the introitus, and bladder with mid trabeculations.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 8755366
• MDR Text Key: 149855065
• Report Number: 2125050-2019-00541
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5148265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female