MAUDE Adverse Event Report: CONVATEC INC. ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 413516

Device Problem Device Handling Problem (3265)

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

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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 further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on october 17, 2016.(b)(4).Not returned to manufacturer.

Event Description

End user reports she is cutting the opening in a 1 piece moldable pouch as the stoma is too big for molding.This caused the stoma to bleed when she sat down or moved.She was unable to quantify the bleeding but stated it was all over her clothing and floor.She experienced 3 episodes of what she described as "more than normal bleeding" and saw her primary physician.She states that the physician was able to see that the pouch was cutting into the stoma causing the bleeding, however she is unable to state if there is a laceration.She was admitted to the hospital on (b)(6) 2016 and discharged home on (b)(6) 2016.She does not know what the admitting diagnosis was.She states lab work was performed with borderline results; no transfusion was necessary.She was given something intravenously while hospitalized but does not know what.She was prescribed doxycycline and prednisone when discharged home.She reports a history of bleeding in the past requiring transfusions but she does not know what type of brand of pouching system was in use at that time.

• Brand Name: ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a haina, san cristobal 3 ; DR 3
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6034028
• MDR Text Key: 57632912
• Report Number: 9618003-2016-00052
• Device Sequence Number: 1
• Product Code: EZQ
• 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
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• 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
• Treatment: AMLODIPINE; FUROSEMIDE; POTASSIUM; SERTRALINE; VARIOUS OVER THE COUNTER (OTC) VITAMINS
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR