MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER ONE PIECE POUCHING SYSTEM WITH FLEXTEND BARRIER AND TAPE BORDER; OSTOMY BARRIER

Model Number 8632

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Skin Tears (2516)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Based on additional information received on june 6, 2017, it was determined that an mdr filing was necessary.The dhr for lot 6kj262 was reviewed and found to be complete and accurate.It appears the individual might be allergic to a component in the tape border.

Event Description

It was reported by the patient that she developed red, itching, bleeding and cracking skin under the tape portion of the barrier.Her doctor prescribed clobetasol propionate 0.5% ointment.She used the ointment twice and switched to a two piece tapeless appliance.Her skin continues to improve and with no further use of the prescribed ointment.

• Brand Name: PREMIER ONE PIECE POUCHING SYSTEM WITH FLEXTEND BARRIER AND TAPE BORDER
• Type of Device: OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 6617807
• MDR Text Key: 76843513
• Report Number: 1119193-2017-00024
• 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: 05/01/2017,06/07/2017

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: 8632
• Device Lot Number: 6J262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 05/01/2017
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 06/07/2017
• 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: 81 YR
• Patient Weight: 75