MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS SUPRAPUBIC SURGIC; SURGICAL MESH

Model Number 5195601000

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

Patient Problems Pain (1994); Cramp(s) (2193)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).Total number of events summarized - 1074: aris - 881, supris - 102, omnisure -60, minitape - 31, total - 1074.

Event Description

As reported to coloplast though not verified, patient's legal representative stated pelvic pain, and suprapubic cramps.

• Brand Name: SUPRIS SUPRAPUBIC SURGIC
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6189558
• MDR Text Key: 62844642
• Report Number: 2125050-2016-00389
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5195601000
• Device Catalogue Number: 5195601000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR