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

Model Number 1281201006

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

Patient Problem Necrosis (1971)

Event Date 08/01/2022

Event Type  Injury  

Event Description

According to the available information, coloplast has initiated a pmcf study as an online survey coordinated by an external partner.When coloplast received the feed-back from the survey an incident was identified, where it was stated that stoma necrosis occurred reportedly related to the use of ostomy rod.No further information available to date.

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.

• Brand Name: OSTOMY ROD
• Type of Device: COLOPLAST OSTOMY ROD
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15632457
• MDR Text Key: 302007081
• Report Number: 3006606901-2022-00017
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1281201006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening