MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT OSTOMY BELT - MEDIUM

Catalog Number 7300

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

Patient Problem Skin Erosion (2075)

Event Date 01/01/1998

Event Type  Injury  

Manufacturer Narrative

User does not know the lot number and does not have any samples from 20 years ago to return so dhr review and sample evaluation is not possible.Trend data reviewed and no adverse trend observed.Based upon the information provided and the fact that the incident took place 20 years ago, little or no information can be obtained from the device history record or other manufacturing information.General review of the product and product performance suggests that the size of the belt selected as well as the patient specific medical conditions could have contributed to this incident.

Event Description

It was reported that an end user developed 2 pressure injuries associated with the use of the hollister ostomy belt.The pressure injuries were located on both sides of his ostomy appliance where the ostomy belt tabs connect to the ostomy appliance.The pressure injures, which were the size of a thumb nail, occurred 20 years ago.The pressure injuries did not fully resolve until 1.5 years ago.At the time of the pressure injuries, he discontinued the use of the ostomy belt, switched to the use of a hernia belt, and sought medical care.The treatment for the pressure injuries continued for 18.5 years and included aquacel ag dressings, cauterization, and prednisone 3 mg crushed tabs placed into his wounds & covered with promogran prisma dressing.It was not until (b)(6) 2018 that hollister became aware of the pressure injuries and the need for medical intervention.

• Brand Name: ADAPT OSTOMY BELT - MEDIUM
• Type of Device: ADAPT OSTOMY BELT - MEDIUM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): SEISA MEDICAL; av. gral roberto fierro 6420,; parque industrial aeropuerto; juarez, chihuahua ; MX
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048-3781 ; 8476802170
• MDR Report Key: 7494989
• MDR Text Key: 107632488
• Report Number: 1480288-2018-00002
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 97