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

Model Number 5195102400

Device Problem Migration (4003)

Patient Problems Inflammation (1932); Pain (1994); Hernia (2240); Constipation (3274)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

The contract manufacturer reviewed the dhr and stated specifications were met.Coloplast reviewed all lot numbers where the reported abiss lot # was associated with.The associated coloplast lot #s are: 3396875, 3375205, 3375206, 3355619, 3355620, 3355621.However, based on the limited information received, coloplast cannot determine which lot # may have been associated with the reported complaint, so all lot #s were reviewed.The review of the coloplast lot #s listed revealed no trend in the complaint, nonconforming report and capa data.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 (b)(6), (b)(6) yo, had surgery in (b)(6) 2012.(b)(6) 2012, the patient could not move in bed.Rx = hernia discale = anti inflammatory = constipation of course.On (b)(6) 2014, the patient went to the emergency room, because the situation and the pain were rendered intolerable, the patient had the impression that the tape would come out of my vagina.Following an evaluation, the band was diagnosed to migrate inside the vagina.So 2nd surgery, (b)(6) 2014 for a partial excision.The patient followed treatments in perineal rehabilitation, which did her good.From time to time she has back and side pain.

• Brand Name: ARIS TRANS-OBTURATOR SLING
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 9287633
• MDR Text Key: 185011284
• Report Number: 2125050-2019-00946
• 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
• Report Date: 11/06/2019

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: Health Professional
• Device Model Number: 5195102400
• Device Lot Number: AL100095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 62 YR