MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO., LTD. CRUTCH AXILLARY ADULT 62-70 300LB

Model Number CA901AD

Device Problem Break (1069)

Patient Problem Contusion (1787)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record for the lot number reported was reviewed and no indications for broken crutches were detected during the production of this lot.A review of the production and finished products inspection records for the past 12 months did not indicate any incidents of crutch tubing breakage during production.A review of the complaint history indicates this is the first reported incident for tubing breakage in the past 12 months.The production lot representative of the crutch that broke was static load tested in accordance with (b)(4) and passed.The actual crutch from this reported issue was not provided.Photos of the crutch were provided and forwarded onto the supplier.The photos did show that the crutch was broken on the bottom tube which is unusual according to the supplier.Based on the information provided for this investigation the root cause could not be determined and therefore no corrective actions will be taken at this time.We will continue to monitor for any similar reports.

Event Description

The consumer reported crutch broke while he was using it, causing him to fall and bang his head, bruise his leg stump (amputee) plus multiple other bruises and scrapes.

• Brand Name: CRUTCH AXILLARY ADULT 62-70 300LB
• Type of Device: CRUTCH AXILLARY ADULT 62-70 300LB
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; gong ting village,; first industrial dist.long xi; bo luo county huizhou city 51612 1; CH 516121
• Manufacturer (Section G): JAN MAO INDUSTRIES CO., LTD.; gong ting village,; first industrial dist.long xi; bo luo county huizhou city 51612 1; CH 516121
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 5628192
• MDR Text Key: 44336113
• Report Number: 1423537-2016-00021
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016,05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CA901AD
• Device Catalogue Number: CA901AD
• Device Lot Number: A400001256SH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2016
• Event Location: Home
• Date Report to Manufacturer: 04/05/2016
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other