MAUDE Adverse Event Report: COLOPLAST A/S TRIAD-STERILIZED 6 OZ TUBE; DRESSING,WOUND,HYDROPHILIC

Model Number 6196701400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Impaired Healing (2378)

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

Patient with diabetic foot ulcer tried the product for 3-4 days and it didn't heal the wound.Used another product initially- regranex.Refer to medwatch (b)(4) for additional details.

• Brand Name: TRIAD-STERILIZED 6 OZ TUBE
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANKATO; 1940 commerce drive; north mankato MN 56003
• Manufacturer Contact: mike bumgarner ; 1601 west river road north; minneapolis, MN 55411
• MDR Report Key: 7465772
• MDR Text Key: 106701031
• Report Number: 2125337-2018-00001
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00311701031324
• UDI-Public: 00311701031324
• Combination Product (y/n): N
• PMA/PMN Number: C042611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6196701400
• Device Catalogue Number: 6196701400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR