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

Model Number 413522

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

Patient Problems Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Height: 70 inches.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 (b)(4).

Event Description

End user reports circumferential peristomal skin redness which extended outward approximately 7mm.He said when he would remove the moldable disc it would strip his skin so he started molding the disc larger than his stoma to avoid this peristomal skin at which time his peristomal skin healed.He did experience pain from this area prior to it healing.

• Brand Name: ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; arque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5105475
• MDR Text Key: 26825846
• Report Number: 9618003-2015-00050
• 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: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2015
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 86