MAUDE Adverse Event Report: HOLLISTER INC. FLEXTEND 1000ML FECAL CONTAINMENT DEVICE; COLLECTOR, OSTOMY

Model Number 9880

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

Patient Problem Skin Tears (2516)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

Patient received a skin tear to the coccyx area when the device was removed.All instructions followed.Hollister flextend 1000 ml 9880 fecal containment device.

• Brand Name: FLEXTEND 1000ML FECAL CONTAINMENT DEVICE
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INC.; 2000 hollister drive; libertyville IL 60048
• MDR Report Key: 8896336
• MDR Text Key: 154407212
• Report Number: 8896336
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2019
• Date Report to Manufacturer: 08/15/2019
• 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: 31025 DA