MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS TALL ADULT WALKLITE WALKER 9153643781; WALKER, MECHANICAL

Model Number 6300-ATA

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Dealer is stating that this unit will not lock into place.

Manufacturer Narrative

Lot number provided.Upon further review, invacare is not the manufacturer.This product was manufactured in (b)(4) by genteel homecare products.The manufacturer will be notified via an oem notification.

Event Description

Dealer is stating that this unit will not lock into place.

• Brand Name: TALL ADULT WALKLITE WALKER 9153643781
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan OH 52821 6; CH 528216
• Manufacturer (Section G): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao nanhai foshan OH 52821 6; CH 528216
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5603858
• MDR Text Key: 44214711
• Report Number: 1525712-2016-01142
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: 6300-ATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1