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

Model Number 5196502400

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Pocket Erosion (2013); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Fungal Infection (2419); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Dysuria (2684); Fluid Discharge (2686); No Information (3190)

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, patient's legal representative stated foreign body reaction, urinary problems, dyspareunia, pain, erosion, bleeding, vaginal scarring, and other injuries.

Manufacturer Narrative

(b)(4).The lot # 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.

Event Description

As reported to coloplast though not verified, additional information received stated dysuria, n/v, hematuria, bladder spasms, uti, straining to void, erosion of vaginal mesh, urgency, urge incontinence, slow urinary stream.On (b)(6) 2017 - excision of sling under general anesthesia, urinary incontinence.On (b)(6) 2018 - back pain abdominal pain flank pain, incomplete emptying pain voiding, incontinence, defecation difficulty, dyspareunia.

Manufacturer Narrative

This follow-up was created to document the additional patient information, date of birth.

Manufacturer Narrative

G6: device code updated from 3190 to 2993 adverse event without identified device or use problem.

Event Description

Additional info received 2/10/2021: between (b)(6) 2017- (b)(6) 2019 urinary retention, severe pain in bladder and lower back, dyspareunia, chronic pelvic pain, high tone pelvic floor myalgia.Additional info rec'd 3/4/2021: between (b)(6) 2017- (b)(6) 2020: difficulty urinating, incomplete bladder emptying, urinary retention, utis, urinary tract spasms, painful urination, feel mesh with intercourse, candidiasis, cystocele, rectocele, bladder prolapse, needing to push on bladder in order to empty, stabbing pain in vagina, stress incontinence.Additional information received on 8/15/2021: between (b)(6) 2016 and (b)(6) 2017: vaginal pain, bladder spasms, pvr 110, dysuria, discharge.Discharge and odor from unspecified site postoperatively.Possible uti, does not feel like she is emptying bladder, abdominal pain and bloating.Postoperative rectal and vaginal pain, bloating.Frequent recurrent yeast infections, dyspareunia, mixed incontinence and urinary frequency.Vaginal odor, urinary retention, abdominal pain with associated dizziness, dysuria, mixed incontinence with incomplete bladder emptying.

• 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 rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 8130693
• MDR Text Key: 129253279
• Report Number: 2125050-2018-00864
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5088007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 11/05/2018; 11/05/2018; 02/10/2021
• Supplement Dates FDA Received: 02/27/2020; 07/16/2020; 08/24/2022
• 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