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

Model Number 416412

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2012

Event Type  malfunction  

Event Description

Report received indicated there was no label printed on the box.No further information was provided.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.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.The product was not returned for an evaluation.A batch record review for this lot was performed.No discrepancies or non-conformances were noted in these batch records related to the complaint reported.A review of complaints for the previous 12 months was performed and there is no indication of complaint trend based on this review.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC CLOSED END POUCH - APS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carr. sanchez, km. 18.5, parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4138061
• MDR Text Key: 4950516
• Report Number: 9618003-2014-11208
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/12/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/26/2017
• Device Model Number: 416412
• Device Lot Number: 2H02240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1