MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR SLING; SURGICAL MESH

Model Number 5195102400

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Constipation (3274)

Event Date 12/01/2012

Event Type  Injury  

Manufacturer Narrative

The contract manufacturer reviewed the dhr and stated specifications were met.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.

Event Description

According to the information provided by health canada, older pain, hips, vagina, thighs, lower back, lower belly, very swollen belly, buttocks pain up to the foot (like something that pulls behind the leg), sometimes difficult to get up because it blocks at groin, can not walk more than 15 minutes (acute lower back pain and weak legs), constipation.The pain wakes her up several times a night and she has to get up about an hour to be able to go back to bed.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.No product was received for evaluation.As examination of the components may not conclusively confirm or disprove the report of pain quality accepts the observations as to the reason for medical intervention.The contract manufacturer was notified of the reported complaint.A review of the complaint history database, non-conformance's and capas revealed no trends for this lot.

• Brand Name: ARIS TRANS-OBTURATOR SLING
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9287627
• MDR Text Key: 166740700
• Report Number: 2125050-2019-00937
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195102400
• Device Lot Number: AF010012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other