MAUDE Adverse Event Report: CONVATEC, INC. NATURA® MOLDABLE STOMAHESIVE® SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 411805

Device Problem Difficult to Remove (1528)

Patient Problem Skin Discoloration (2074)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.A batch record review found no discrepancies related to this complaint.Process checks and quality checks were performed with acceptable results.The returned sample was evaluated and found to conform to specification.There was no evidence of any defect to confirm the complaint.(b)(4).Note: this complaint issue occurred on ((b)(4)) separate cases.A separate 3500a form has been completed for the other ((b)(4)) cases.

Event Description

It was reported the adhesive at the tape collar is sticking too much to the skin making it difficult to remove the wafer, even with using adhesive remover.End user reports skin redness after removing the wafer.

• Brand Name: NATURA® MOLDABLE STOMAHESIVE® SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• 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: 6103339
• MDR Text Key: 59975844
• Report Number: 1049092-2016-00470
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• 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: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 411805
• Device Lot Number: 6C03457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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