MAUDE Adverse Event Report: CONVATEC INC; DRESSING, WOUND, HYDROPHILIC

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problem Use of Device Problem (1670)

Patient Problems Bacterial Infection (1735); Pain (1994); Blood Loss (2597); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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.Additional information has been requested; however, to date no additional information has been received.The lot number was not provided.Therefore, we are unable to determine the specific manufacturing site.Two (2) potential manufacturing site numbers are listed below.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the end user had a total right knee replacement on (b)(6) 2018.On post operation day six (6), end user reports increased pain to the knee.On post op day nine (9), end user began seeing red rash coming beyond the dressing borders.Dressing was removed at this point and end user prescribed oral benadryl, hydrocortisone cream and medrol pak.On (b)(6) 2018, end user reports her incision line opened in a tiny area to the medial patella tendon, described as a pinhole.This area exhibited a large amount of puss and drainage of blood.End user was placed on clindamycin and the area closed after seven days with scab formation.This same area reopened (b)(6) 2018 and end user was again placed on clindamycin.End user returned to dermatologist on (b)(6) 2018 and a wound culture was performed which confirmed a staph infection.Physician did not indicate that the dressing caused the staph infection.

• Type of Device: DRESSING, WOUND, HYDROPHILIC
• 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
• MDR Report Key: 8248400
• MDR Text Key: 133076603
• Report Number: 1049092-2019-00004
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: WOUND CARE-UNKNOWN SURGICAL COVER DRESSI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65