MAUDE Adverse Event Report: UNOMEDICAL S.R.O. ESTEEM + ONE-PIECE PRE-CUT CLOSED-END POUCH; POUCH, COLOSTOMY

Model Number 416704

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on june 27, 2016.(b)(4).This complaint issue occurred on (2) separate cases.A separate 3500a form has been completed for each case.

Event Description

It was reported that the wafer is too sticky and sticks too firmly.There was no harm reported.

Manufacturer Narrative

No physical sample has been received.Lot number was verified and is valid for the reported model number.A batch record review indicated no discrepancies.No non-conformance related to complaint issue was observed during manufacturing process.Device history records associated with the reported lot number were reviewed.All relevant tests required during manufacturing process and the final product releasing was performed and met test requirements.The process parameters adjusted during production were reviewed.All process parameters were adjusted within validated process window.This issue will be monitored through the 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 + ONE-PIECE PRE-CUT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce, 07101 ; LO 07101
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5752607
• MDR Text Key: 48302738
• Report Number: 3005778470-2016-00006
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Model Number: 416704
• Device Lot Number: 219415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• 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