MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXTEND DRAINABLE POUCH WITH TAPE BORDER

Catalog Number 8331

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

End user's weight not provided so estimate used.Lot number not known so dhr review not possible.Sample not returned so sample review is not possible.Trend analysis conducted for this sku and problem type and no adverse trends observed.The root cause of the end user's skin irritation cannot be determined.

Event Description

It was reported that an end user started experiencing skin irritation under the hollister ostomy barrier in december.They tried nystatin powder under the barrier to treat the irritation but it did not help.They have since given him 5 doses of fluconazole to treat the irritation.The skin is now less excoriated but now has pustules.

• Brand Name: PREMIER FLEXTEND DRAINABLE POUCH WITH TAPE BORDER
• Type of Device: PREMIER FLEXTEND DRAINABLE POUCH 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, IL 60046-3781 ; 8476802170
• MDR Report Key: 11231471
• MDR Text Key: 228855191
• Report Number: 1119193-2021-00003
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8331
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• 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 Weight: 68