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

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Fungal Infection (2419); No Code Available (3191)

Event Date 10/01/2013

Event Type  Injury  

Event Description

It was reported the end user developed a rash to her peristomal skin while hospitalized in (b)(6) 2013.The rash was reportedly red, itchy and prickly and extended to the edge of the device mass.The rash has reportedly persisted and has spread to areas under the end user's breasts and abdominal pannus.The pt sought treatment from her general practitioner in the (b)(6) 2014 and was issued a prescription for the unk antifungal ointment.The pt noted improvement to the areas when the ointment is applied.As the ointment interferes with her appliance-to-skin adhesion, the pt has been unable to use the antifungal ointment with any frequency.The pt was encouraged to work with her general practitioner to obtain a different type of antifungal and was provided with information on the crusting technique.No further pt complications were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional patient/event details, including the model (icc code) and lot numbers, have been requested.No additional details have been provided to date.Should additional information become available, a follow-up report wil be submitted.

• Brand Name: CONVATEC ONE-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc. dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4826501
• MDR Text Key: 5843267
• Report Number: 1049092-2015-00312
• 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: 05/21/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/08/2015
• 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: LYRICIA,; OMEPRAZOLE FOR GERD,; MEDICATONS: LISINOPRIL FOR HYPERTENSION,; SYMBALTA.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR