MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

Catalog Number 11204

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 05/24/2019

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 not possible because not number not known.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.The root cause of the stoma content leakage cannot be determined.

Event Description

It was reported that the end user experienced a burning and itching rash on her skin from her knees to her waist from ileostomy output.She reported that when the hollister barrier got wet from her output, it would not adhere to her skin and leak.She went to the er and was hospitalized overnight.She was discharged home on ciprofloxacin and fluconazole.Hollister is sending her a convex barrier product to try.

• Brand Name: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CERAPLUS 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: 8687597
• MDR Text Key: 147721985
• Report Number: 1119193-2019-00023
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• 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: 76 YR
• Patient Weight: 102