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

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Abdominal Cramps (2543); Dysuria (2684); Kidney Infection (4502); 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.Device not returned.

Event Description

As reported to coloplast, though not verified, legal representative stated dyspareunia, pelvic pain, groin pain, thigh pain, vaginal pain, rectal pain, and recurring urinary tract infections, among other symptoms.Plaintiff is currently receiving medical treatment for her injuries and is expected to undergo mesh removal surgery, pelvic floor injections and/or bilateral pudendal nerve blocks as well as a burch procedure sometime in the coming months.No other adverse patient effects were reported.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.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

Legal representative stated dyspareunia, pelvic pain, groin pain, thigh pain, vaginal pain, rectal pain, and recurring urinary tract infections, among other symptoms.Plaintiff is currently receiving medical treatment for her injuries and is expected to undergo mesh removal surgery, pelvic floor injections and/or bilateral pudendal nerve blocks as well as a burch procedure sometime in the coming months.

Manufacturer Narrative

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

Event Description

Additional information received on 11/6/202 as follows: between (b)(6) 2019 and (b)(6) 2022 the patient was experiencing urinary tract infection symptoms with spontaneous urgency and frequency and can feel mesh inside.Painful sex with deep penetration.Continued daily pelvic pain.Dysuria and interstitial cystitis.Lower abdominal cramping.Pain with walking.On (b)(6) 2021 the patient underwent surgery for removal of the altis sling, a burch procedure, cystoscopy, left ovarian cystectomy, bilateral salpingectomy, bilateral pudendal nerve block, and botox injection to pelvic floor muscles.Post operative hypovolemic shock lasting until (b)(6) 2014.Remained hypotensive despite fluid resuscitation.Ct abdomen and pelvis completed, suggestive of pelvic hematoma anterior to the urinary bladder with moderate hemoperitoneum.Transferred to icu and emergently taken to or.On (b)(6) 2014 a diagnostic laparoscopy was performed with evacuation of the hematoma.

Event Description

Additional information received on 6/16/2023 indicates the patient is experiencing rectal bleeding upon bowel movement and burning with urination.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13007381
• MDR Text Key: 282401649
• Report Number: 2125050-2021-01779
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2023

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: Lay User/Patient
• Device Expiration Date: 06/24/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6740824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female