MAUDE Adverse Event Report: HOCOMA AG LOKOMATPRO; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Catalog Number	32001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Skin lesions (including pressure sores) in areas of contact with harness support, robotic orthosis (buttocks and along lower extremities) or lower extremity loading (feet).There are populations with sensitive skin and comorbidities that impact the skin.The clinician in charge has the sole medical responsibility for the rehabilitation treatment and for deciding whether a patient is fit for a specific treatment.In particular, the clinician must weigh in each individual case the possible risks and side effects against the expected benefits.In addition, the patient's individual situation plays just as important a role as the basic risk assessment for specific patient groups.The treating clinician is responsible for adapting the training sessions and the course of therapy to the patient's abilities.
Event or Problem Description
Initially left gluteal fold bruising as a result of lokomat use.Developed into stageable iv wound.

• Brand Name: LOKOMATPRO
• Common Device Name: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): HOCOMA AG; industriestrasse 4; volketswil, 8604 ; SZ 8604
• Manufacturer (Section G): HOCOMA AG; industriestrasse 4; volketswil, 8604 ; SZ 8604
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 14462245
• Report Number: 3003781275-2022-00002
• Device Sequence Number: 4570125
• Product Code: IKK
• UDI-Device Identifier: 07640174660254
• UDI-Public: 7640174660254
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 79 KG