MAUDE Adverse Event Report: ETHICON INC. BONE WAX; WAX, BONE

Catalog Number W810

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Date 01/06/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a pulmonary lobectomy procedure on (b)(6) 2013 and bone wax was used.On (b)(6) 2014, the wound had exudate and was still not healed.The patient went to the hospital.After inspection, bone wax was found in the white exudate and debridement was performed.Currently, the patient is fine.

Manufacturer Narrative

It was reported that the bone wax was used for hemostasis of the sternum and it was not removed at the end of the procedure.After the wound was debrided, the wound healed with no further complications.

Manufacturer Narrative

(b)(4).Conclusion: the product upon which this medwatch is based is anticipated.Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Conclusion: representative samples were returned for evaluation.They were visually and functionally examined and they met the requirements.

• Brand Name: BONE WAX
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC. - UK; simpson parkway, kirkton campu; s; livingston EH54 7AT; UK EH54 7AT
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3599761
• MDR Text Key: 4164591
• Report Number: 2210968-2014-01183
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PRE-AMMEND
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: W810
• Device Lot Number: GC5BSLM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2013
• 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): Required Intervention
• Patient Age: 50 YR