MAUDE Adverse Event Report: CONVATEC INC. NATURA PCH DRN STD TAN 45MM; BAG, URINARY, ILEOSTOMY

Model Number 125927

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.A detailed investigation or batch review is not required.If additional complaints occur with this batch and with the same malfunction code, these subsequent complaints shall be assessed against the batch criteria data.This issue will be monitored through the post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 01, 2016.(b)(4).

Event Description

As reported by a hospital worker, the pouch leaked through closed clip, which reportedly led to an urinary tract infection.The end user was treated with an oral antibiotic and the infection resolved with no further symptoms.

• Brand Name: NATURA PCH DRN STD TAN 45MM
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5765285
• MDR Text Key: 48658163
• Report Number: 9618002-2016-00031
• Device Sequence Number: 1
• Product Code: EXH
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2021
• Device Model Number: 125927
• Device Lot Number: 6B01640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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