MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXWEAR DRAINABLE POUCH WITH FILTER AND TAPE BORDER; PREMIER FLEXWARE DRAINABLE POUCH WITH FILTER AND TAPE BORDER

Catalog Number 8081

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/08/2019

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 no issues identified.Trend data reviewed and no trend observed.The root cause of the end users generalized rash cannot be determined.

Event Description

It was reported that an end user experienced a rash over his whole body and itching associated with the use of the ostomy appliance.End user was prescribed hydroxyzine pills and instructed to use hydrocortisone cream.He states it helps a little.

• Brand Name: PREMIER FLEXWEAR DRAINABLE POUCH WITH FILTER AND TAPE BORDER
• Type of Device: PREMIER FLEXWARE DRAINABLE POUCH WITH FILTER AND 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, IL 60046-3781 ; 8476802170
• MDR Report Key: 8518471
• MDR Text Key: 142075645
• Report Number: 1119193-2019-00011
• 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: 04/16/2019

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: 8081
• Device Lot Number: 9A132
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/16/2019
• 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: 66 YR
• Patient Weight: 74