MAUDE Adverse Event Report: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. DUODERM EXTRA THIN CGF (CONTROL GEL FORMULA); DRESSING, WOUND, OCCLUSIVE

Model Number 187955

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by the nurse that the product is not available to paste well near picc (venous indwelling needle) wound skin, about 3cm place of the normal skin.There was no reported harm to the pt.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.Additional info was requested.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.Note: this issue occurred on (15) separate pts at the same facility.A separate 3500a form has been completed for the other (14) cases.

• Brand Name: DUODERM EXTRA THIN CGF (CONTROL GEL FORMULA)
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4840379
• MDR Text Key: 5875352
• Report Number: 1049092-2015-00329
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K891696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 187955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1