MAUDE Adverse Event Report: CONVATEC, INC. LITTLE ONES ACTIVELIFE ONE-PIECE CUSTOM DRAIN; POUCH, COLOSTOMY

Model Number 020922

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

Patient Problems Erythema (1840); Rash (2033); Ulcer (2274)

Event Type  Injury  

Event Description

It was reported that the end user developed peristomal ulcer at the three to six o'clock position.In addition, the patient had developed a red, bumpy rash under the wafer.At the time of the call, the patient had reportedly cut the center hole of the wafer to a size larger than necessary to accommodate her stoma.The patient was provided with instruction on proper fit and sizing of her wafer to her stoma.Finally, she was instructed on proper crusting technique.

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: LITTLE ONES ACTIVELIFE ONE-PIECE CUSTOM DRAIN
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak,interim dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4510158
• MDR Text Key: 21331396
• Report Number: 9618003-2015-00006
• 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: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 020922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 25 YR