MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; BAG, URINARY, ILEOSTOMY

Model Number 650831

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user stated that the barrier covered the stoma at times when first applied.He changed every 4 days.The product was used and no harm was reported.No photo is available at this time.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Lot 0d04898 was manufactured on 5/13/2020 in the convex 1 pc manufacturing line, with a total of 560 market units.On 31/may/2021, compliance engineer id 6053 performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material 1004089, icc code 650831 and manufacturing order 1519748.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instruction pi21-076.The process requirements results were documented in the manufacturing records mr21-076.In addition, the batch record of bulk lot 0d03915, manufactured in the elc6 manufacturing line, was reviewed and no issues were found; the lot ran according to sap material 1002590, all the testing results were found satisfactory.The process was run according to process instruction pi22-057, documented in mr22-057.Batch record review supports that no issues regarding the failure mode reported were identified.On 31/may/2021 a complaint search for lot 0d04898 and malfunction code ost-pmc1.12 / ost-pmc1.12 skin barrier migrates and obstructs stoma was carried out and as a result, no additional complaints were found; therefore, no trend is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (either by photo, video or sample provided by the customer, or as a result of the batch record review) and no potential trend is identified.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: ACTIVELIFE
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 10814963
• MDR Text Key: 215473053
• Report Number: 9618003-2020-15090
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 650831
• Device Lot Number: 0D04898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1