MAUDE Adverse Event Report: CONVATEC INC. NATURA® + DRAINABLE POUCH WITH INVISICLOSE®; POUCH, COLOSTOMY

Model Number 416419

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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 november 09, 2016.

Event Description

Complainant reports that the pouch ring is not smooth.It cut a patient's stoma and caused bleeding.The device had been in use about 24 hours.It was further reported that the device was removed.

Manufacturer Narrative

A batch record review was acceptable and indicated no discrepancies related to this complaint.Process checks and quality checks were performed with acceptable results.A photograph was received for this complaint and was evaluated however, conformity to specification could not be confirmed and 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).

• Brand Name: NATURA® + DRAINABLE POUCH WITH INVISICLOSE®
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6090217
• MDR Text Key: 59515360
• Report Number: 9618003-2016-00055
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2020
• Device Model Number: 416419
• Device Lot Number: 5H00273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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 Outcome(s): Required Intervention