MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 401512

Device Problems Incomplete or Missing Packaging (2312); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2011

Event Type  Injury  

Event Description

Report received indicated that materials manager ordered 14 boxes from convatec and received 13 with labels and 1 without label.Reports do not have boxes available to confirm lots of 13 boxes with label.Product has been replaced.There was no patient involvement.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.This complaint applies to the surfit natura pchdrn std clr45mm icc (b)(4).The lot number could not be obtained.A review of the batch record and retain evaluation could not be performed without a lot number.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this icc.There was no objective evidence of nonconformity.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4072342
• MDR Text Key: 4830790
• Report Number: 9618003-2014-10251
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 401512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1