MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM

Catalog Number 88402

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

End user's weight is not known so an estimate was used.Despite numerous attempts, unable to reach end user for further information.Lot number was not provided so dhr review is not possible.Sample not provided so sample examination not possible.Trend analysis conducted and no trend observed for this product and issue.The root cause of the reported skin irritation and infection cannot be determined.

Event Description

An ostomate reported that her skin was raw and burning from stool getting on her skin under the ostomy appliance.The doctor told her it was an infection and gave her antibiotics.No other information is known.

• Brand Name: PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM
• Type of Device: PREMIER SOFTFLEX DRAINABLE OVAL CUT TO FIT ONE PIECE POUCHING SYSTEM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 8988855
• MDR Text Key: 161687343
• Report Number: 9616668-2019-00004
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 88402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 104