MAUDE Adverse Event Report: CONVATEC INC. ESTEEM + MOLDABLE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 413521

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Skin Erosion (2075); Blood Loss (2597)

Event Date 04/01/2015

Event Type  Injury  

Event Description

The end user reported her skin was red; open and bleeding under the mass soon after her surgery; approximately one month ago.She mentioned that leakage from under the mass resulted in her skin irritation.She was hospitalized on (b)(6) 2015 due to excoriated peristomal skin.She further mentioned that antibiotics (name unk) were ordered for her for this event.Due to this event, her nurse discontinued the prod and a competitors prod is being used.She advised that her skin is much improved at present with less redness and open areas present.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.Add'l pt/event info requested.No add'l pt/event details have been provided to date.Should add'l info become available a f/u report will be submitted.

Manufacturer Narrative

Additional information received november 19, 2015.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM + MOLDABLE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a. ; san cristobal 3, haina ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4833425
• MDR Text Key: 5907133
• Report Number: 9618003-2015-00029
• 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,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2015
• 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: BREAST CANCER DRUG (UNK NAME); ZANTAC; PRILOSEC
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 72