MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE (SH.); POUCH, COLOSTOMY

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Date 04/29/2011

Event Type  Injury  

Event Description

Report received indicated the pt experienced a red peristomal rash underneath the entire mass.Pt experienced this condition for an unk period prior to complaint receipt.Pt outcome was not noted.

Manufacturer Narrative

The lot number could not be obtained, therefore, a review of the batch record and retain eval could not be performed without a lot number.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this icc code.There is no indication of complaint trend based on this review.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE (SH.)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4029711
• MDR Text Key: 4842161
• Report Number: 9618003-2014-10011
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2014
• Device Model Number: 022771
• Device Lot Number: 1B02916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention