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

Model Number 187955

Device Problem Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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

It was reported "the dressing was less absorption." the dressings were used on either the face or the leg/hand.The dressings were in place for one day.No harm was reported.It was unknown the number of dressings used.Follow up information was requested for the exact location and it could not be confirmed by the reporter.No photographs were provided.

Manufacturer Narrative

(b)(6).(b)(4).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 pi29-006 automatic chevron sleeve packaging bodolay c.In addition, a complaint search for lot 9f02754 and malfunction code wnd-pmc2.1 dressing/ribbon/gel handles insufficient wound exudate or does not retain absorbed wound exudate was carried out and as a result, no additional complaints were found; therefore, no trend for this lot is observed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092 manufacturing site: 9618003.

Event Description

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

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 10245738
• MDR Text Key: 197963795
• Report Number: 9618003-2020-12121
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 9F02754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1