MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS CRUTCH; 890.3150

Model Number 6153

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

It was reported that the pin that holds the adjustment height no the crutch is sliding inside the tubing.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan 5282 16; CH 528216
• MDR Report Key: 3737410
• MDR Text Key: 4225801
• Report Number: 1531186-2014-01261
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/09/2014,03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2014
• Distributor Facility Aware Date: 03/11/2014
• Date Report to Manufacturer: 04/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other