MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Scarring (2061); Swelling (2091); Tissue Damage (2104); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Injury (2348); Prolapse (2475); Abdominal Cramps (2543); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, patient's legal representative stated foreign body reaction, dyspareunia with bleeding, abdominal cramping, lower back pain, anxiety, and other injuries.

Manufacturer Narrative

This follow-up was created to document the additional device and patient information.The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.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.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and explant date.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 the mesh was removed.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported to coloplast though not verified, swelling/discomfort, mild urinary urgency, pelvic cramping, pelvic pressure, mild bulging, pelvic/vaginal pain.(b)(6) 2017 - partial excision of altis, cystocele repair with soft tissue excision, vaginal mucosa tripping, cystoscopy - slight adhesion to periurethral tissue, small rectocele, scarring, foreign body reaction, benign vaginal squamous epithelium.(b)(6) 2017 - surgical site soreness, vaginal discharge (b)(6) 2017 - dyspareunia, post-coital spotting, atrophic vaginitis.(b)(6 2017 - (b)(6) 2017 - llq pain radiating to low back/neck with daily headaches since coloplast implant/removal surgeries.(b)(6) 2017 - mri pelvis -granulation tissue from vaginal cuff along posterior bladder.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn, MN 55411 ; 6123024982
• MDR Report Key: 7139231
• MDR Text Key: 95527628
• Report Number: 2125050-2017-00637
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 5124761
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR