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

Model Number 5195512400

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Rash (2033); Urinary Retention (2119); Burning Sensation (2146); Discomfort (2330); No Information (3190)

Event Date 06/06/2011

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 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), intense pain in the lower abdomen - uterus, left ovary, vagina ca burns bladder does not empty in full, hip pain, cocci, rashes, spit in the vagina and urete, can not sit for long, and standing up long make me a pressure in the uterus as inflammation, no longer force because very painful after right leg freeze like at the dentist on the front of the thigh, calf pain -cramps- and gluteal and its all along 2 legs, sleeps almost no position, urine with 2 to 3 jets.

• Brand Name: ARIS TRANS-OBTURATOR 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: sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9288359
• MDR Text Key: 165961453
• Report Number: 2125050-2019-00983
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• 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
• Device Operator: Health Professional
• Device Model Number: 5195512400
• 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