MAUDE Adverse Event Report: JINHUA TWINSTAR TOOLS CO. LTD. DRIVE MEDICAL; HYGIENE ADAPTOR

Model Number RTL13094

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/10/2014

Event Type  Injury  

Event Description

(b)(4) has received a call from claimant on an incident involving a suction grab bar imported and distributed by (b)(4).Claimant stated that she was holding onto the grab bar when she was getting out of her shower.When she turned around, she fell and hit her head on base of her sink.Claimant sought medical attention and allegedly received three staples on her head.She did not report the incident to (b)(4) until four months later.This mdr report is based on the information provided by the claimant.

• Brand Name: DRIVE MEDICAL
• Type of Device: HYGIENE ADAPTOR
• Manufacturer (Section D): JINHUA TWINSTAR TOOLS CO. LTD.; jinhua ; CH
• Manufacturer (Section G): MEDICAL DEPOT; 99 seaview blvd.; port washington NY 11050
• Manufacturer Contact: 99 seaview blvd.; port washington, NY 11050
• MDR Report Key: 4024889
• MDR Text Key: 4849551
• Report Number: 2438477-2014-00010
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/15/2014,07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL13094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2014
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 48