MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2FS -0- PDO 14 X 14

Model Number SXPD2B418

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Swelling/ Edema (4577)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided so a batch review of the finished good lot and components could not be performed at this time.To date photos or samples have not been returned for review and/or analysis.There were no retained samples available for testing.If additional information or sterile samples are received a follow-up report will be filed.Adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation which skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the barbed suture device.Without receiving sterile devices from the same finished good lot for review/testing or receiving photos of the incision site or growth or receiving detailed information regarding, pre-operative preparation of the devices, placement of the suture material in the tissue, patient health history, identification of the growth and/or surgeons technique, a definitive root cause cannot be determined at this time.

Event Description

It was reported by the sales rep that post op of a hysterectomy procedure that the patient experienced a reaction to the suture.Stratafix was used to stitch the vaginal cuff and patient experienced swelling, inflammation, or a ¿growth¿.Surgeon removed the ¿growth¿ on an unknown date, but the ¿growth¿ or inflammation is coming back.

• Brand Name: STRATAFIX
• Type of Device: 2FS -0- PDO 14 X 14
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 12487757
• MDR Text Key: 271891545
• Report Number: 3010692967-2021-00040
• Device Sequence Number: 1
• Product Code: NEW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021,09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Date Manufacturer Received: 09/09/2021
• 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; Required Intervention