MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

Model Number 187959

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Common device name ¿ dressing, wound, occlusive.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Per the information for use (ifu), the maximum recommended wear time for this product is up to seven (7) days.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported after application once on patient, the dressing is difficult to remove from the patient.It was further reported that the product was used for ten (10) days.No harm was reported.

Manufacturer Narrative

As stated in the batch records of bulking lots manufactured on the extruder laminating 10 machine, materials were used as indicated in the bill of material (bom), a line clearance was performed at the start of manufacturing operation and at the end of the process; furthermore, periodic reviews of line clearance requirements are performed at the start-up of each shift and after electrical or major mechanical adjustments.On (b)(6)2018 , an extraordinary maintenance was performed to the extruder laminating 10 machine, while running the lot number 8c04850 (item 1003413) by the maintenance area, related to ¿failure in the cooling tower¿.However, this failure does not impact the properties of the products based on quality testing results.The adhesives test and the ¿strip to strip t-peel was performed for the first piece or after machine stop with satisfactory results.The required visual inspection testing was performed per hours.Dimensions and product characteristics testing were performed every half hour; the overall thickness was found in range.All quality and manufacturing testing were considered acceptable and process parameters were properly set as documented.Finally, inspections are performed by quality to the packaged product and all results were satisfactory.On (b)(6)2019 , a query was performed to each individual impacted lot (final and bulking lots) in the system to confirm if any local event, such as rework or nonconformance occurred during the manufacturing process of those lots regarding to the same failure mode reported.As result, not events were found related to this failure mode.On (b)(6)2019 , a query was run from (b)(6)2019 to (b)(6)2018 to cover the full year in the system looking for customers reporting complaints, associated to the reported malfunction in the doyen a machine.As result, a total of six (06) complaints were found associated to the mentioned failure mode (including the ones triggering this nonconformance).No negative trend is observed, based on the total quantity manufactured of impacted final lots.Based on the initial assessment performed through revision of the batch records documentation, pictures provided by customers in complaints reported and process evaluation, this event could not be confirmed due to samples were not available to measure dressing dimensions, could not be confirmed if products were used during the recommended period as established in the instruction for use.Recommended medical instructions were properly followed for the product 8c05035.No local events were found related to manufacturing requirements as per batch records review of bulking and final lots.However, a defect notification was given to quality and manufacturing assigned to the extruder laminating 10 machine to make them aware of complaints reported by customers.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

Additional information was provided confirming that the product was used for fourteen (14) days, and not ten (10) days that was initially reported.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8027727
• MDR Text Key: 125767987
• Report Number: 9618003-2018-03118
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2020
• Device Model Number: 187959
• Device Lot Number: 187959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1