MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TWO-PIECE POUCHING SYSTEM; NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 14603

Device Problems Inadequacy of Device Shape and/or Size (1583); Inadequate User Interface (2958)

Patient Problem Laceration(s) (1946)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

No sample received and no lot number provided.Without the sample or lot number hollister is unable to perform a full investigation regarding the event.Trend analysis conducted and no negative trends observed.End user stated that she did not know that she was cutting her barrier opening too small causing it to cut into her stoma.

Event Description

It was reported that an end user's stoma was bleeding and she couldn't figure out why.She went to the er where the bleeding area was cauterized.She later found out that the ostomy barrier edges that she was cutting to fit her stoma, was being cut too small, causing it to rub against and cut her stoma causing it to bleed.She has since cut the barrier opening bigger and it is no longer cutting her stoma.

• Brand Name: NEW IMAGE TWO-PIECE POUCHING SYSTEM
• Type of Device: NEW IMAGE FLEXTEND SKIN BARRIER 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. 60048-3781 ; 8476802170
• MDR Report Key: 8888582
• MDR Text Key: 154148010
• Report Number: 1119193-2019-00035
• 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: 08/13/2019

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: 14603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Weight: 62