C-LEG KNEE JOINT 3C98-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-10-02 for C-LEG KNEE JOINT 3C98-2 manufactured by Otto Bock Healthcare Products Gmbh.

Event Text Entries

[27301284] No resistance of joint while walking. Patient fell. No serious injuries (only bruises).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9615892-2015-00001
• MDR Report Key: 5123026
• Report Source: DISTRIBUTOR
• Date Received: 2015-10-02
• Date of Report: 2015-10-02
• Date Mfgr Received: 2015-04-09
• Device Manufacturer Date: 2014-06-02
• Date Added to Maude: 2015-10-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. REINHARD WOLKERSTORFER
• Manufacturer Street: BREHMSTRASSE 11
• Manufacturer City: VIENNA, VIENNA 1110
• Manufacturer Country: AU
• Manufacturer Postal: 1110
• Manufacturer G1: OTTO BOCK HEALTHCARE PRODUCTS GMBH
• Manufacturer Street: BREHMSTRASSE 11
• Manufacturer City: VIENNA, VIENNA 1110
• Manufacturer Country: AU
• Manufacturer Postal Code: 1110
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: C-LEG KNEE JOINT
• Generic Name: EXTERNAL ABOVE KNEE PROSTHESIS
• Product Code: ISW
• Date Received: 2015-10-02
• Returned To Mfg: 2015-09-08
• Model Number: 3C98-2
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OTTO BOCK HEALTHCARE PRODUCTS GMBH
• Manufacturer Address: BREHMSTRASSE 11 VIENNA, VIENNA 1110 AU 1110

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-10-02