MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	93-4400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient was implanted on (b)(6) 2017.At a follow-up on (b)(6) 2017, the patient experienced erosion of the strip, which was treated locally on each occasion, with a recommendation to apply a topical estrogen.It is noted that the patient does not follow the recommendations.A third erosion occurs on (b)(6) 2019.A complex multifactorial problem associated with possible pudendal nerve involvement was revealed.The patient refuses local treatment and prefers to consult outside (usa).She was assessed on (b)(6) 2021, and the bandlet was radically retreated on (b)(6) 2021.The consultation made no mention of neurological damage and focused on strip erosion associated with infection and pain.The follow-up shows an improvement in vaginal pain, but no great improvement in chronic generalized multifactorial pain or in left pudendal neuropathy.
Additional Manufacturer Narrative
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.Coloplast routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.B3: estimated date.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20558612
• Report Number: 2125050-2024-01745
• Device Sequence Number: 8996165
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 93-4400
• Device Lot Number: 5397650_5195512400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female