MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.9 DRIVE; SHOWER CHAIR

Model Number 12203KD-1

Device Problem Material Fragmentation (1261)

Patient Problem Bruise/Contusion (1754)

Event Date 03/03/2019

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a shower chair.End-user is represented by an attorney.Information regarding the incident are minimal.We are filing this report in an overabundance of caution since a serious injury was reported.Device reportedly broke while in use causing bruising, nerve pain, and sciatica.Device is not expected to be returned for evaluation.We will file a follow-up submission when information becomes available.

• Brand Name: DRIVE
• Type of Device: SHOWER CHAIR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.9; west of tanjialing road; yuyao zhejiang; 31540 8; CH 315408
• MDR Report Key: 8830414
• MDR Text Key: 152320053
• Report Number: 2438477-2019-00047
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 07/26/2019,05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12203KD-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Distributor Facility Aware Date: 05/31/2019
• Date Report to Manufacturer: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention