MAUDE Adverse Event Report: CONVATEC INC

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Aquacel/ aquacel ag surgical cover dressing.Dressing, wound, hydrophilic.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.The complainant was unable to provide the model number, lot number or product sizing information.Therefore, we are unable to determine the specific manufacturing site.Both potential manufacturing site numbers are listed.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported there was one primary package of aquacel ag that is not sealed.The product was not used.No photograph was provided.

• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): 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: 10734508
• MDR Text Key: 213042454
• Report Number: 1049092-2020-00175
• Device Sequence Number: 1
• Product Code: NAC
• 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,health professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1