MAUDE Adverse Event Report: VALENTINE INTL. LTD. CAREX; ROLLATOR

Model Number FGA22200 0000

Device Problem Defective Component (2292)

Patient Problems Laceration(s) (1946); Limb Fracture (4518)

Event Date 08/05/2020

Event Type  Injury  

Event Description

Has had since 2012.The left brake was holding.Was in the nursing home and she thought that the brakes were adjusted during the 5 1/2 years that she was in there.2 weeks ago she went to sit on it and it scooted away from her causing her to fall.When she fell she hit her right arm on an open part that covers the spring of the brake on the right side.It cut her arm from her elbow down to her wrist.She also hit her right hand on the freezer handle and broke her right hand.She saw a doctor several times.She feels that the rollator is in perfect shape even though it is 12 years old.She doesn't know the last time that the brakes were adjusted.They did steri-strips and then bandages because of her age.They put a splint on her hand.She broke the metatarsal bone that goes to the little finger.As far as she knows the brakes were locked before she sat on it.She always locked the brakes before she sits on it.

• Brand Name: CAREX
• Type of Device: ROLLATOR
• Manufacturer (Section D): VALENTINE INTL. LTD.; 8th fl., no. 149, sec. 2; ta tung rd.; hsichih city, taipei hsien, taipei TW 22 1; TW TW 221
• MDR Report Key: 10514808
• MDR Text Key: 206342031
• Report Number: 3012316249-2020-00028
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22200 0000
• Device Catalogue Number: A222-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Distributor Facility Aware Date: 08/19/2020
• Device Age: 12 YR
• Event Location: Other
• Date Report to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 56