MAUDE Adverse Event Report: ETHICON, INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPD2B420

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Wound Dehiscence (1154)

Event Date 06/16/2022

Event Type  Injury  

Event Description

Five (5) episodes of wound dehiscence after use of ethicon stratafix.All procedures were spinal procedures.Episodes ranged from (b)(6) 2022 to (b)(6) 2022.All 5 episodes required the patient to return to surgery.(b)(4).

• Brand Name: STRATAFIX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 15249648
• MDR Text Key: 298325588
• Report Number: MW5111556
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPD2B420
• Device Lot Number: AAIB068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other