MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 14704

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review conducted based upon the lot number provided and found to be accurate and complete.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user developed itching, burning and blistering under the tape portion of her ostomy barrier starting in the beginning of (b)(6) 2018.The blisters did not break open and there was no bleeding.The rash did not resolve by trying different ostomy products recommended by her wound care nurse so she went to a dermatologist.He administered a steroid injection which worked almost immediately.No allergy testing or patch testing was performed.Although the area cleared up, the rash returned in the beginning of (b)(6).She phoned the doctor who said it was a reaction to the adhesive in the tape.He said she needs to try a paper tape or tapeless appliance.End user called hollister for a sample and a tapeless appliance will be sent to her to try.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8476802170
• MDR Report Key: 7564734
• MDR Text Key: 109899478
• Report Number: 1119193-2018-00022
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14704
• Device Lot Number: 8C292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73