MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT

Catalog Number 14604

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.Dhr reviewed and found to be complete and accurate.Actual end user weight is not known so an estimate was used.In vivo skin sensitization testing is performed to identify the potential risk of an allergic response.Some individuals may still be sensitive to a specific material that has met all sensitization test requirements and the severity of their response cannot be predicted.Root cause of this reported issue cannot be determined.

Event Description

It was reported that an end user experienced a reaction under the tape and barrier portion of the ostomy appliance.This reaction, over time, spread to her whole body.Her doctor prescribed topical steroids and oral antihistamines.She was also treated for a yeast infection.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT
• Type of Device: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER - CUT TO FIT
• 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: 9375062
• MDR Text Key: 167989119
• Report Number: 1119193-2019-00042
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2019

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: 14604
• Device Lot Number: 8K132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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: 18 YR
• Patient Weight: 59