MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the patient used the dressing which was hard to remove from skin because of its too strong adhesiveness.No photo is available at this time.

Event Description

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

Manufacturer Narrative

No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 1c01811 and malfunction code (b)(4) adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure wi-(b)(4) version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed.Lot 1c01811 was manufactured on 03/31/2021, doyen b, with a total of (b)(4) units.A batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.Sap material 1000915 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.No additional action is required, and this complaint will be closed.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 9618003.

• Brand Name: L3W0750 - DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 13547574
• MDR Text Key: 285987101
• Report Number: 9618003-2022-00174
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 1C01811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/21/2023
• Date Device Manufactured: 03/31/2021
• 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