MAUDE Adverse Event Report: CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK

Lot Number 362463

Device Problem Sticking (1597)

Patient Problem Injury (2348)

Event Date 06/26/2015

Event Type  Injury  

Event Description

A blue u-drape was used for proximal row carpectomy, excision of synovial cyst, repair of flexor carpi ulnaris tendon on (b)(6) 2015.During removal of the surgical drape, a large skin tear was noted on the proximal forearm, approximately 8 cm x 10 cm.The large skin avulsion is suspected to be secondary to the unusually adhesive plastic drapes that were used to isolate the operative site.Plastic foreign body was carefully removed from the forearm.Area debrided, sutured.Silvadene cream and dressing applied.Debridement and split-thickness skin graft performed on (b)(6) 2015.

• Brand Name: CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK
• Type of Device: CARDINAL - BLUE U-DRAPE IN HAND/ELBOW PACK
• MDR Report Key: 4929774
• MDR Text Key: 17633972
• Report Number: 4929774
• Device Sequence Number: 1
• Product Code: KKX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/01/2019
• Device Lot Number: 362463
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2015
• Distributor Facility Aware Date: 06/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 120