AMERICAN ORTHOPAEDIC 0295-200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-27 for AMERICAN ORTHOPAEDIC 0295-200 * manufactured by Bsn Medical, Inc.

Event Text Entries

[3132565] Physical therapist (pt) was opening a window on the cast on the right leg on the anterior portion of the ankle. The cast saw apparently was allowed to contact the skin which resulted in a small red area and small open area. The physician assistant was contacted and the wounds were treated and a bandage applied. On tuesday, a different dressing was ordered by the physician. On wednesday, a 2nd cast was applied and a window created to view the wound. Three small horizontal linear red areas were noted and the top one had a small open area. The bottom two areas are likely the result of the stocking material wrinkling under the cast, or the edge of the cast and the top one as a result of the cast coming in contact with the skin. The area was cleaned and a topical antibacterial applied and mepilex dressing applied prior to casting. On thursday morning, the physician assessed the wound and noted that the patient was complaining of pressure and pain in the area above the wound - likely a result of the cast being too tight. The cast was removed by the pt. Rehab educator to develop competency reviews for serial casting for our dept. Serial casting is infrequently performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2992557
• MDR Report Key: 2992557
• Date Received: 2013-02-27
• Date of Report: 2013-02-27
• Date of Event: 2013-02-18
• Report Date: 2013-02-27
• Date Reported to FDA: 2013-02-27
• Date Reported to Mfgr: 2013-03-07
• Date Added to Maude: 2013-03-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMERICAN ORTHOPAEDIC
• Generic Name: SAW
• Product Code: LGH
• Date Received: 2013-02-27
• Model Number: 0295-200
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BSN MEDICAL, INC
• Manufacturer Address: 100 BEIERSDORF DR RUTHERFORD COLLEGE NC 28671 US 28671

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-02-27