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

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No components will be received for evaluation.However, as examination of the components may not conclusively confirm or disprove the reports of exposure, quality accepts the physician¿s observations as to the reason for medical intervention.As no lot number was provided a review of the complaint database, nonconforming reports or capas could be completed.The reported complaint has been forwarded to the supplier.

Event Description

According to the available information, a physician at the facility stated that there have been a number of aris exposures over the last 3.5 years.The physician stated the average exposure was ¿excessive midline, complete mucosal exposure with the width of the sling¿ and ¿the sling seemed loose and not incorporated by any new tissue.¿ the physician also stated that for many of the cases they attempted to reclose tissue over the exposed and unincorporated mesh only to have them re-expose and need another operation to excise and remove the exposed mesh.The physician stated that there were no serious or outlying patient co-morbidities.The physician did not know the dryness efficacy of the patients and did not know whether the patients had their slings tensioned the appropriate amount.The exact number of reports/patients could not be confirmed as attempts to obtain further information have been unsuccessful to date.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• 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: ussoga sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10485199
• MDR Text Key: 205485582
• Report Number: 2125050-2020-00792
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• 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): Hospitalization; Other; Required Intervention