MAUDE Adverse Event Report: COLOPLAST A/S MIO430 1P OPW MX W/W 40-45; ADHESIVE / BASEPLATE

Model Number 1047901400

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problems Abrasion (1689); Burn(s) (1757); Unspecified Infection (1930)

Event Date 01/22/2016

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

End user's wear time started coming loose in 3-4 hours, then lasted 1 day max.Skin began to burn after 3 days of this due to leakage.Would lift at bottom and on sides.Skin was infected, had abrasions; went to er, and a nurse advised for him to do crusting routine with powder and barrier spray and repeat as needed.Unclear whether it was truly infected per se.The skin has healed well and it is fine now.This was not his first time using the product.

• Brand Name: MIO430 1P OPW MX W/W 40-45
• Type of Device: ADHESIVE / BASEPLATE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S THISTED; industrivej 7, 7700; thisted, ; DA
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5404544
• MDR Text Key: 37307750
• Report Number: 9610694-2016-00002
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2016
• Device Model Number: 1047901400
• Device Catalogue Number: 1047901400
• Device Lot Number: 4597089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR