MAUDE Adverse Event Report: ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195511400

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

Patient Problems Bacterial Infection (1735); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for aug-sept 2017.This mdr is to reflect the additional information to be added to the initial asr report.(patient information and event details).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for aug-sept 2017.This mdr is to reflect the additional information to be added to the initial asr report.As reported to coloplast though not verified, additional information received stated a resection of the vaginal mesh and cystoscopy was performed on (b)(6) 2019.Previously a resection of the suburethral sling meash and cystoscopy was performed on (b)(6) 2019.Pt had bilateral obrurator muscle spasm prior to her most recent surgery.In (b)(6) of 2019, it was noted that pt is doing well with minimal discomfort on the left side of the vagina.And she is happy with her bladder function at this time.

Manufacturer Narrative

This follow-up mdr is created to document the corrected date below, corrected model number and udi, and the review of lot number.The previous report stated "previously a resection of the suburethral sling mesh and cystoscopy was performed on (b)(6) 2019".This date was reported as 8/23/2016, not (b)(6) 2019.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

Manufacturer Narrative

H6 patient code 3191 used for "squamous epithelium with focal reactive epithelial changes and focal changes suggestive of low grade squamous intraepithelial lesion (mild dysplasia, cin 1), ", oab, nocturia, and "levator muscle/pudendal nerve dysfunction" h6 device code 3190 selected for exposure 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 right adduction tendon tenderness, left lateral vaginal introitus tenderness, uti associated with suprapubic pressure/frequency/urgency/flank discomfort, urgency.(b)(6) 2015: vaginal biopsy showed squamous epithelium with focal reactive epithelial changes and focal changes suggestive of low grade squamous intraepithelial lesion (mild dysplasia, cin 1), dyspareunia.(b)(6) 2016: bladder ultrasound showed hyperechoic linear structure within the left side most likely represents the bladder sling.Pyelonephrtis, + e.Coli, uti + strep/staph.(b)(6) 2019: exposure, vaginitis, oab, nocturia, levator muscle/pudendal nerve dysfunction.(b)(6) partial excision/revision of mesh.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• MDR Report Key: 9682776
• MDR Text Key: 184825933
• Report Number: 2125050-2020-00134
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2020

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: Lay User/Patient
• Device Model Number: 5195511400
• Device Lot Number: 1670892
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR