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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This report is related to a clinical evaluation report; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: evaluation of performance and safety outcomes of ethicon bone wax.Postprocedural bleeding within 90 days post-index procedure: 1,058 patients, defined as the presence of an icd-10-cm diagnosis code for postprocedural hemorrhage or postprocedural hematoma (see appendix 1) as a primary or secondary diagnosis during the index admission where a study device was used or during a re-admission within 90 days post-index procedure.Icd-10-cm diagnosis codes.Surgical site infection within 90 days post-index procedure: 724 patients, defined as the presence of an icd-10-cm diagnosis code for surgical site infection, mediastinitis, or osteomyelitis (see appendix 2) as a primary or secondary diagnosis during the index admission where a study device was used or during a re-admission within 90 days post-index procedure.Icd-10-cm diagnosis codes.

• Brand Name: BONE WAX UNKNOWN PRODUCT
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18928988
• MDR Text Key: 337987053
• Report Number: 2210968-2024-03163
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other