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

Model Number 5196502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, physician states patient presented extreme groin and leg pain and weakness on left side (dynamic anchor) immediately post op.She treated with steroids and rest for 1 week and pain reduced.Soon after, came back and surgeon explanted sling but left anchors in place and she put a retropubic sling in instead.Patient continued to complain of leg pain.As of (b)(6), surgeon said patient may have had pelvic and leg pain prior to initial sling surgery on the (b)(6) and has been sent for psychiatric work up.According to surgeon, patient seems to very sensitive to touch and most areas of her body and has multiple comorbidities.Unsure of final resolution to this patients leg/groin complaint.

• Brand Name: ALTIS KIT
• 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: christine buckvold
• MDR Report Key: 6392627
• MDR Text Key: 69511110
• Report Number: 2125050-2017-00048
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/09/2017

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: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other