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

Model Number WOUND CARE-UNKNOWN SURGICAL COVER DRESSI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Skin Discoloration (2074); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Brand name: aquacel/aquacel ag, surgical cover dressings.Affiliation: (b)(6) medical center.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.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 knee replacement that developed cellulitis under the aquacel ag scd resulting in the need for a poly exchange and irrigation and drainage, as well as antibiotics (names unknown).It was further reported that the routine is to use alcohol to clean surgical prep area followed by chloraprep stick, then drape then another chloreaprep stick applied.After surgery is complete, the joint is injected with a "joint cocktail" (details not provided).The wound is closed using dermabond and cleansed with normal saline, after drape is removed the dressing applied.It was noted that the dressing is not warmed prior to application.The physician is suspecting it may have been applied by the same clinician and she may have stretched the dressing prior to application.The area was presented as scabbed, red and swollen along the incision line.No photograph was provided and no current status of the end user was provided.

• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8799445
• MDR Text Key: 151338657
• Report Number: 9618003-2019-04644
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 07/03/2019
• 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