CAST VAC 986 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-11 for CAST VAC 986 * manufactured by Stryker Instrument.

Event Text Entries

[3086478] Patient seen by md with bilateral casts placed at another facility for club feet. Cast needed to be removed to make sure no open fracture. Once cast removed noticed a small abrasion area on the right medial malleolus. Md inspected area and reassured parents it was only a minor abrasion. The area was cleaned, bacitracin applied and band aid placed. ======================manufacturer response for cast cutter, stryker (per site reporter). ======================several components replaced and device was returned to hospital to be put back in to use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2802373
• MDR Report Key: 2802373
• Date Received: 2012-10-11
• Date of Report: 2012-10-11
• Date of Event: 2012-09-16
• Report Date: 2012-10-11
• Date Reported to FDA: 2012-10-11
• Date Added to Maude: 2012-10-24
• 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
• Reporter Occupation: RISK MANAGER
• 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: CAST VAC
• Generic Name: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Product Code: LGH
• Date Received: 2012-10-11
• Returned To Mfg: 2012-09-18
• Model Number: 986
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: R
• Device Age: 15 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER INSTRUMENT
• Manufacturer Address: 4100 EAST MILHAM AVE KALAMAZOO MI 49001 US 49001

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-10-11