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

Catalog Number 14705

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.Dhr review done and found to be complete and accurate.The root cause of the reported contact dermatitis cannot be determined.

Event Description

It was reported that an end user developed contact dermatitis and distant site reaction to the barrier and tape.The rash was described as redness under the appliance and blotchy redness and itching on her side and back which started approximately (b)(6).She went to the doctor who prescribed triamcinolone acetonide cream 0.1% 1-2x/day.A week later, when that didn't help, the doctor prescribed oral medrol dose pak.She will trial other hollister products to see if it improves.

• 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 INCROPORATED; 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, IL 60048-3781 ; 8476802170
• MDR Report Key: 7716323
• MDR Text Key: 114936353
• Report Number: 1119193-2018-00027
• 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: Other
• Type of Report: Initial
• Report Date: 07/25/2018

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 Catalogue Number: 14705
• Device Lot Number: 8E212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/24/2018
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 47