MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT; OSTOMY BARRIER

Model Number 14803

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Skin Tears (2516)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

The dhr for lot 6k082 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 itchy skin under the tape portion of the barrier.The irritation continued and started resulting in skin stripping.Her doctor prescribed triamcinolone 0.1% cream which she is applying twice a day by removing her appliance.Based on her doctor's recommendation she will also try otc benadryl.She has allergies to pcn and environmental allergies.She has not yet seen a wocn.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT
• 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: 6538195
• MDR Text Key: 74212363
• Report Number: 1119193-2017-00018
• 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: 04/07/2017,05/02/2017

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: 14803
• Device Lot Number: 6K082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 04/07/2017
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/02/2017
• 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: 53 YR
• Patient Weight: 73