MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE ONE-PIECE DRAINABLE PRE-CUT POUCH; POUCH, COLOSTOMY

Model Number 125340

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

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Type  Injury  

Event Description

The end user reported that he has developed an ulcer that has been ongoing for at least three years.The ulcer is described as superficial, red and bleeds at times.His most recent visit to his physician was about three months ago.A physician prescribed oral sucralfate four times a day to prevent ulcer, as well as oral and cream antibiotics (names not provided), and his ulcer was swabbed.Discussed stoma size and skin care.Suggested to follow up with local home care provider and ostomy nurse.

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: ACTIVELIFE ONE-PIECE DRAINABLE PRE-CUT 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, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4360287
• MDR Text Key: 15966599
• Report Number: 9618003-2014-00114
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• 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: AND MUSCLE SPASMS.; TAKES EIGHT MEDICATIONS (NAMES UNKNOWN) FOR; PAIN, DIABETES, STOMACH (DETAILS NOT PROVIDE),
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 96