MAUDE Adverse Event Report: CONVATEC INC.; PROTECTOR, OSTOMY

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional information was requested but, no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

End user reports his stoma was irritated by durahesive moldable convex skin barrier causing bleeding around the stoma that was exacerbated by warfarin doses required for atrial fibrilation, as well as waist and belt position.

Manufacturer Narrative

(b)(4).No lot number or sample is available for evaluation.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

This supplemental report is being submitted as a retraction for follow-up# 01, mfr report# 1049092-2016-00244 submitted on (b)(6) 2016 under patient identifier# (b)(6) in error.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5683206
• MDR Text Key: 46067469
• Report Number: 1049092-2016-00244
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR