MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX MONODERM

Model Number SXMD1B105

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

To date the samples have not been received by surgical specialties corporation for root cause and failure analysis. To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of wound dehiscence, a definitive root cause cannot be determined at this time. When and if additional information is received a follow-up report will be filed.

Event Description

Out affiliate is reporting a patient returned to the surgeon with a case of dehiscence.

• Brand Name: STRATAFIX
• Type of Device: MONODERM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; rd. 495 montana industrial pk; aguadilla PR 00605
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; rd 495 montana indusrial park; aguadilla PR 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8394841
• MDR Text Key: 137973796
• Report Number: 3010692967-2019-00009
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2022
• Device Model Number: SXMD1B105
• Device Lot Number: MDVT390,MDVZ020
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial