MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM AND ONE-PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 416718

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

Patient Problems Erythema (1840); Skin Erosion (2075); Skin Irritation (2076); Fluid Discharge (2686)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported that seven to ten days ago the end user developed red dots that developed into two wounds in the peristomal area.The wounds are both round and measure thirteen millimeters with a depth of three millimeters and located thirteen millimeters from stoma base.They are described as red and weepy.The husband of the end user also stated that the end user has other intact red dots which are present in the peristomal area as well.Approximately one week ago, it was stated the end user saw her physician, who prescribed bactrim ointment.Then on (b)(6) 2015 the end user was prescribed bactrim oral.At that time she was referred to a university wound clinic for further treatment options.The end users husband was also encouraged follow-up with wound ostomy care nurse, if concerns persist or worsen.

Manufacturer Narrative

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

• Brand Name: ESTEEM AND ONE-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a. haina; san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4531242
• MDR Text Key: 5516645
• Report Number: 9618003-2015-00007
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 416718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• 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: LASIX; MEDICATIONS: FOR CARDIAC ISSUES AND
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 49