MAUDE Adverse Event Report: COLOPLAST A/S OSTOMY ROD STERILE; ROD, COLOSTOMY

Model Number 1281201008

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

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 11/12/2018

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, the patient had a sub-acute operation, implanted a loop-ileoostomy over an ostomy rod on (b)(6) 2018.Patient was checked by a doctor on (b)(6) 2018, where the loop-ileoostomy was intact and the ostomy rod was placed under the ostomy ridge.Ostomy rod was freely moving.Plan was made to bandage the stoma with the ostomy rod.Due to the rupture of the facie - patient was re-operated on (b)(6) 2018.During this operation, it was described that the stoma had a lesion of the backside.After the operation, it was described that the stoma was bleeding and that the stoma had "ruptured".It is not known, in which situation the ostomy rod has caused decay of the loop-ileoostomy.

• Brand Name: OSTOMY ROD STERILE
• Type of Device: ROD, COLOSTOMY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 8213566
• MDR Text Key: 131964736
• Report Number: 3006606901-2019-00002
• Device Sequence Number: 1
• Product Code: EZP
• Combination Product (y/n): N
• PMA/PMN Number: K052229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1281201008
• Device Catalogue Number: 1281201008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other