MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG BONE WAX; WAX,BONE

Model Number BW25G

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect.Another surgery had been necessary to resolve the case.The patient is alive.No additional information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: during spin surgery, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect.There was an appearance of a hematoma and another surgery had been necessary to resolve the case.The patient is alive.No additional information was provided the current patient status is ok.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A review of the manufacturing and quality records for this lot found no reports relating to dry or crumbling product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: BONE WAX
• Type of Device: WAX,BONE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6661905
• MDR Text Key: 78226446
• Report Number: 1219930-2017-05853
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 20884521196268
• UDI-Public: 20884521196268
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Device Lot Number: 16041458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention