MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM ONE-PIECE PRE-CUT CLOSED-END POUCH; POUCH, COLOSTOMY

Model Number 416707

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Fungal Infection (2419); Fluid Discharge (2686)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported the end user began using the esteem on-piece pre-cut closed -end pouch in (b)(6) 2015 after she developed a peristomal yeast rash while using another manufacturer's product (coloplast).The end user is alternating the esteem one-piece pre-cut closed-end pouch and a pouch from another manufacturer (coloplast).In addition, the end user was issued a prescription for nystatin powder by her physician; however, the rash has persisted and the end user's peristomal skin was described as red, open and weepy.The end user consulted her physician a second time and was issued a prescription for diflucan.The rash has not improved with the diflucan.The end user was referred to her physician for further treatment.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: ESTEEM ONE-PIECE PRE-CUT CLOSED-END 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, int assc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4861441
• MDR Text Key: 5811395
• Report Number: 9618003-2015-00030
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/22/2015
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DIAL SOAP; NYSTATIN POWDER; OTHER MEDICATIONS; MORPHINE; NEURONTIN; CAVILON NO STING BARRIER WIPE; LYRICA
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73