MAUDE Adverse Event Report: A & I INDUSTRIES LTD MEDLINE GUARDIAN BARIATRIC HEAVY DUTY PUSH BUTTON CRUTCHES

Catalog Number MDS80335XW

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

Crutches came in with a substance that looked like tiny balls of metal inside the sealed package.
=
manufacturer response for heavy duty push button crutches, guardian (per site reporter).
=
i contacted the distributor.That is where we get the crutches from.They are sending me shipping material to send the crutches back.

• Brand Name: MEDLINE GUARDIAN BARIATRIC HEAVY DUTY PUSH BUTTON CRUTCHES
• Type of Device: CRUTCHES
• Manufacturer (Section D): A & I INDUSTRIES LTD; 33 golden eagle lane; littleton CO 80127
• MDR Report Key: 4837584
• MDR Text Key: 5932547
• Report Number: 4837584
• Device Sequence Number: 1
• Product Code: INP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/09/2015

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: Invalid Data
• Device Catalogue Number: MDS80335XW
• Device Lot Number: 40315010001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1