MAUDE Adverse Event Report: HOLLISTER INCORPORATED MODERMA FLEX CONVEX FLEXTEND TRANSPARENT UROSTOMY 38 MM CUT TO FIT POUCH

Model Number 29701

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Skin Irritation (2076); Discharge (2225)

Event Type  Injury  

Event Description

It was reported by the consumer that he developed 4 skin infections while using the moderma flex convex cut to fit urostomy pouch with flextend barrier and adhesive border.The patient had been using the product for about 2 years and had his first infection approximately 6 months ago.The infection was treated with antibiotics.The patient had also been using hollister barrier wipes and adhesive remover which he discontinued using.He has since developed 3 additional infections each of which was treated with oral antibiotics.His stoma care nurse felt it could be caused by a number of things but he did not elaborate.There was no pain or bleeding just weepy and reddish areas under both the skin barrier and adhesive.Bacterial infection was confirmed by swab.His stoma care nurse switched him to another product but irritation still developed under the device.

Manufacturer Narrative

The root cause of the skin reaction can not be determined.

• Brand Name: MODERMA FLEX CONVEX FLEXTEND TRANSPARENT UROSTOMY 38 MM CUT TO FIT POUCH
• Type of Device: OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 999
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 4293365
• MDR Text Key: 5274196
• Report Number: 1119193-2014-00023
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/03/2014,12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 29701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 11/03/2014
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 12/03/2014
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 83