MAUDE Adverse Event Report:

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Brand name: ostomy-unknown wafer, common device name: protector, ostomy, product code: exe, manufacturer: convatec inc.(b)(4).Model#: ostomy-unknown wafer.Based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.Additional information has been requested but nothing has been received to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the end user that she was provided convatec cut-to-fit wafers by her home care nurse sometime in 2006 or 2007 and when she cut them, the cut edges felt sharp.The end user reports she had a small amount of bleeding from her stoma and thinks it was caused by the sharp edge.The end user changed out the wafers to larger moldable ones and the bleeding resolved and has not recurred.No further harm was reported by the patient.No pictures were available and no further details have been provided.

• MDR Report Key: 6842086
• MDR Text Key: 84718729
• Report Number: 1049092-2017-00047
• Device Sequence Number: 1
• Product Code: EZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR