MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. UNKNOWN CONVATEC CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/28/2015

Event Type  malfunction  

Event Description

It was reported the end user noted blood had dropped into the pouch after cutting the wafer to fit.The end user indicated she may have left a jagged edge on the wager which, in turn, cut the stoma.The end user was referred to her physician for treatment.No further pt complications were reported as a result of this event.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.Reported to the fda on (b)(6) 2015.(b)(6).

• Brand Name: UNKNOWN CONVATEC CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4921139
• MDR Text Key: 16880851
• Report Number: 9618003-2015-00036
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/15/2015
• 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: Initial
• Patient Sequence Number: 1
• Treatment: MEDICATIONS: PLAVIX
• Patient Age: 81 YR
• Patient Weight: 50