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

Model Number 125927

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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.A detailed investigation or batch review is not required at this time.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.(b)(4).

Event Description

It was reported that 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.

Manufacturer Narrative

It was reported on the initial mfr report #9618003-2016-00030, submitted to the fda on june 30, 2016 that a detailed investigation is not required at this time.This was reported in error.The investigation is complete and the results are as follows: batch records for lot # 6b01640 was performed and indicates no discrepancies.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run accordingly.The process requirements results were documented in the product batch records.The product was packed and labeled according to the required specifications.No non-conformances (nc), deviations or discrepancies were found during revision.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).

Manufacturer Narrative

This supplemental report is being submitted to retract the initial mdr submitted on june 30, 2016 with mfr report# 9618003-2016-00030 and the supplemental follow-up report 01 submitted on october 06, 2016 with mfr report# 9618003-2016-00030, as with further review there was not enough information provided to make the connection regarding the reported product to cause harm to the patient, nor was there a device malfunction reported, therefore, this is deemed as non-reportable.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: NATURA PCH DRN STD TAN 45MM
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; director, quality complaint; handling unit, 7900 triad ctr; dr., ste 400 greensboro,, NC 27409 ; 3365424681
• MDR Report Key: 5763434
• MDR Text Key: 48616565
• Report Number: 9618003-2016-00030
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• 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: 06/13/2017
• 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