MAUDE Adverse Event Report: UNOMEDICAL LTD. OP-HANDLE POOLE/X-RAY; OPERATION HANDLES

Model Number 33035181

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

It was reported that a foreign object was found (in the form of a long black hair) in one of the products.

Manufacturer Narrative

Based on the available info this event is deemed a reportable malfunction.No add'l patient/event details have been provided to date.Should add'l info become available a f/u report will be submitted.A return sample for evaluation is not expected.

• Brand Name: OP-HANDLE POOLE/X-RAY
• Type of Device: OPERATION HANDLES
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk districk; minsk region 2227 50; BO 222750
• Manufacturer Contact: matthew waleciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3994342
• MDR Text Key: 17386852
• Report Number: 3007966929-2014-00069
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33035181
• Device Catalogue Number: 33035181
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1