KIN-COM 125 A/P 5352

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-04-19 for KIN-COM 125 A/P 5352 manufactured by Chattanooga Group, Inc..

Event Text Entries

[127949] Pt undergoing routine exercise (3rd visit) for rehabilitation. During 2nd set of 10 repetitions, "pta" heard a pop and discontinued treatment. X-rays revealed fractured patella. Pt had extremely strong quad muscles 4 plus to 5. "pta" stated there was nothing wrong with device, as it is still in use today.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1022819-1999-00001
• MDR Report Key: 220103
• Report Source: 05
• Date Received: 1999-04-19
• Date of Report: 1999-04-17
• Date of Event: 1999-03-22
• Date Mfgr Received: 1999-03-24
• Device Manufacturer Date: 1994-06-01
• Date Added to Maude: 1999-04-27
• 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: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KIN-COM 125 A/P
• Generic Name: ISOKINETEC TESTING AND EVALUATION SYSTEM
• Product Code: IKK
• Date Received: 1999-04-19
• Model Number: 125 A/P
• Catalog Number: 5352
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 213460
• Manufacturer: CHATTANOOGA GROUP, INC.
• Manufacturer Address: 4717 ADAMS RD. HIXSON TN 37343 US
• Baseline Brand Name: KIN-COM 125 A/P
• Baseline Generic Name: ISOKINETEC TESTING AND EVALUATION SYSTEM
• Baseline Model No: 125 A/P
• Baseline Catalog No: 5352
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-04-19