MAUDE Adverse Event Report: CONVATEC INC. DUODERM® EXTRA THIN CGF® (CONTROL GEL FORMULA); DRESSING, WOUND, OCCLUSIVE

Model Number 187955

Device Problems Material Disintegration (1177); Appropriate Term/Code Not Available (3191)

Patient Problem Skin Tears (2516)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Product information for use states the following for removal of the product: press down on skin with one hand and carefully lift one corner.Continually stretch horizontally until dressing is fully removed (dressing will stretch like taffy).For fragile skin, gradually remove dressing from one corner-using saline or sterile water between skin and adhesive-until dressing is fully removed.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.Follow up has been requested, but no additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: two cases associated with this complaint.A separate fda form 3500a has been completed for the known amount and the known patient associated with this complaint.

Event Description

Reporter stated that the hospital protocol is to put a secondary tape over the product which "is generally used in protection of the face and as a second skin for secondary tapes deemed too harsh on a newborn's skin.For example: gastric tube, endotracheal tube, respiratory interface - the product is used as a second skin and ideally left on the skin." reporter stated that when the product is used with a secondary tape that may need to be changed daily, the product "comes off the face with the secondary tape requiring unnecessary peeling of tape off the face.The product is 'overtly' sticky to handle and has caused skin tears on the face when peeling off." reporter stated "when the product is required to be removed, at times it does not come off as a whole piece but breaks up into smaller pieces making it difficult to handle.".

• Brand Name: DUODERM® EXTRA THIN CGF® (CONTROL GEL FORMULA)
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5568897
• MDR Text Key: 42375404
• Report Number: 1049092-2016-00152
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K891696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2016

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?: No
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/11/2016
• 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: Unknown
• Patient Sequence Number: 1