MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT OSTOMY BELT

Model Number 7300

Device Problem Use of Device Problem (1670)

Patient Problem Skin Discoloration (2074)

Event Date 05/22/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, the patient who used the adapt ostomy belt, went to his dermatologist for a reddened welt area on his skin.The reddened area was located under the buckle of his adapt ostomy belt and was noted to be 3/4" by 4-5".The area was not raised and did not itch; the skin remained intact.The patient had previously tried over the counter ointments and changed to a new belt.The dermatologist performed a skin biopsy which came back negative and prescribed desonide 5% to treat the redness.The dermatologist said the reddened area was strictly an abrasion.The reddened area was showing improvement with the application of the desonide.The patient had used a total of 6 belts over approximately 5 months and thought it may have been on a little too tight.

• Brand Name: ADAPT OSTOMY BELT
• Type of Device: OSTOMY BELT
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): SEI MEDICAL S.A. DE C.V.; parque industrial aeropuerto; roberto fiero #6420 & francisc; juarez, CP32 685; MX CP32685
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 4861996
• MDR Text Key: 5845295
• Report Number: 1480288-2015-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/23/2015

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: 7300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 77 YR
• Patient Weight: 91