ARIS TRANSOBTURATOR SLING (ABISS)
Report
- Report Number
- 2125050-2023-00682
- Event Type
- Injury
- Date Received
- June 2, 2023
- Date of Event
- September 10, 2008
- Report Date
- June 19, 2025
- Manufacturer
- ABISS - ANALYTIC BIOSURGICAL SOLUTIONS
- Product Code
- OTN
- UDI-DI
- 03600040101612
- PMA / PMN Number
- K050148
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- 003
Narratives
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED.
CORRECTION: MEDICAL DEVICE PROBLEM CODE A24 REMOVED. 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. A CLINICAL ASSESSMENT OF THE RECEIVED MEDICAL RECORDS WAS EXECUTED. IT WAS IDENTIFIED THE PATIENT HAD A PRE-EXISTING CONDITION (FIBROMYALGIA) WHICH IS LISTED IN THE ARIS SLING IFU AS A CONTRAINDICATION FOR USE OF URETHRAL SUSPENSION SLINGS, INCLUDING ARIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE RE-EVALUATED AND UPDATED ACCORDING TO CURRENT PROCEDURES. NO FURTHER ACTION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
CORRECTION: HEALTH EFFECT CLINICAL CODE E232401 AND E1008 REMOVED. 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. A CLINICAL ASSESSMENT OF THE RECEIVED MEDICAL RECORDS WAS EXECUTED. IT WAS IDENTIFIED THE PATIENT HAD A PRE-EXISTING CONDITION (FIBROMYALGIA) WHICH IS LISTED IN THE ARIS SLING IFU AS A CONTRAINDICATION FOR USE OF URETHRAL SUSPENSION SLINGS, INCLUDING ARIS. COMPLAINTS OF THIS NATURE ARE MONITORED AND CAPTURED WITHIN THE PRODUCT RISK DOCUMENTATION EXCEPT FOR FECAL INCONTINENCE, EMOTIONAL CHANGES, DIARRHEA, OR CONSTIPATION. THERE ARE NO CLINICAL STUDIES OR LITERATURE TO SUPPORT A SPECIFIC CAUSAL RELATIONSHIP BETWEEN ARIS AND FECAL INCONTINENCE, EMOTIONAL CHANGES, DIARRHEA, OR CONSTIPATION AS A SIDE EFFECT. NO FURTHER ACTION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THE LOT NUMBER 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. LOT NUMBER AH060050.
AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT EXPERIENCED PLASTIC OPERATIONS ON THE VAGINA IN 2012 AND BOTOX INJECTIONS TO TRIGGER POINT IN THE LEFT MONS PUBIS IN 2024.
AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT ALSO EXPERIENCED MESH EXPOSURE AND MESH INFECTION. THE PATIENT UNDERWENT EXCISION OF THE INFECTED MESH IN 2018.
AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED VAGINAL DRYNESS, REDUCED LIBIDO, CONSTIPATION, IRREGULAR BOWEL HABIT, ABDOMINAL BLOATING, OVARIAN CYSTS, ABDOMINAL PAIN, BACK PAIN, LOOSE STOOLS, BOWEL INCONTINENCE, FRANK INCONTINENCE, DIARRHEA, BOWEL URGENCY, FIBROMYALGIA, GROIN PAIN, GROIN ABSCESSES, URINARY TRACT INFECTIONS, STRONG SMELLING URINE, DYSPAREUNIA, STRESS INCONTINENCE, URGE INCONTINENCE, POST MICTURITION DRIBBLE, VAGINAL BLEEDING, VAGINAL PAIN, PILES, VAGINAL DISCHARGE, LEG PAIN, DYSURIA, FREQUENCY, RECURRENT THRUSH AND PATIENT HAS BEEN AFFECTED PSYCHOLOGICALLY.
AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE, PAIN, YEAST INFECTIONS AND URINARY TRACT INFECTIONS POST MESH EXCISION. ADDITIONALLY, THE PATIENT UNDERWENT FURTHER BOTOX INJECTIONS FOR LEFT GROIN PAIN.
AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT UNDERWENT A SOFT TISSUE ULTRASOUND IN 2022 WHICH FOUND RESIDUAL MATERIAL IN MONS PUBIS AREA AROUND AN OLD SCAR, THE PHYSICIAN IS UNSURE IF THIS IS MESH RELATED. THE PATIENT ALSO EXPERIENCED ATROPHIC VAGINITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1089722 | ARIS TRANSOBTURATOR SLING (ABISS) | FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER | OTN | ABISS - ANALYTIC BIOSURGICAL SOLUTIONS | UR31011020 | AH060050_UR31011000 | 03600040101612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |