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

Catalog Number 8331

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.User does not know the lot number and did not save any of the appliances from the box of product that initiated the redness.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user developed a skin rash under the ostomy barrier in the beginning of (b)(6) 2018.The rash was described as redness.He went to the doctor who prescribed nystatin cream.The rash resolved but came back again the beginning of (b)(6) 2018.He was prescribed nystatin powder which cleared up the rash as well.

• 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: 7494971
• MDR Text Key: 107621296
• Report Number: 1119193-2018-00019
• 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: Patient
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• 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: 59 YR
• Patient Weight: 102