MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY MFG. CO., LLC; LIGATURE WIRE

Model Number WPLW25

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  No Answer Provided  

Manufacturer Narrative

Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture.The product involved in the event does not have an expiration date.Reprocessor does not apply no concomitant medical products and therapy dates provided.Pma/510(k) is not applicable.Ind is not applicable.

Event Description

A patient experienced an allergic reaction after her cheekbone was stabilized with 25 gauge stainless steel wire.

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: LIGATURE WIRE
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO., LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 6178528
• MDR Text Key: 62536318
• Report Number: 1416605-2016-00008
• Device Sequence Number: 1
• Product Code: DYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WPLW25
• Device Catalogue Number: WPLW25
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other