MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; SH 0 MONODERM 20CM

Model Number	SXMD1B406
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	07/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.No samples or photos of the surgical site were available for review.If samples or photos become available at a later time, they will be evaluated, and the results will be included in the file.A follow-up report will be submitted at that time.As stated in the ifu for the devices, ¿adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.Past reactions to suture material or medications, the placement of the suture, over-tightening of the material without receiving photographs of the incisions/post-operative conditions, or receiving pertinent details regarding the procedure performed, placement of the suture material in the tissue, condition of the tissue where the suture was placed, patient''s health status, post-operative event(s) that may have contributed to the reported condition, number of days post-operative when the inflammation presented, culture results or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The health authority reported to our distributor after the patient was admitted to the hospital and completed the relevant auxiliary examinations, he received surgery.After the surgery, the doctor gave the patient anti infection, detumescence and pain relief, prevention of deep vein thrombosis and symptomatic treatment.After the surgery, the wound dressing was strengthened.After the surgery, the patient's dressing was removed and dressing was changed, and the red and swelling of the lower part of the right thigh were significantly relieved, and the touch pain was less than before.The surgical opening of the front side of the right thigh was red, swollen, tender, and a little oozing.The rest of the surgical opening was normal, the patient''s rejection and adverse reactions to suture.Continue to provide patients with anti-infection, swelling reduction, pain relief, and symptomatic support treatment, and strengthen dressing changes at the surgical site.

• Brand Name: STRATAFIX
• Common Device Name: SH 0 MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22245 ; MX 22245
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood MA 02090
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22245 ; MX 22245
• MDR Report Key: 17184156
• Report Number: 3010692967-2023-00024
• Device Sequence Number: 6452435
• Product Code: GAM
• UDI-Device Identifier: 10705031228030
• UDI-Public: (01)10705031228030(20)12(17)270531(10)C601HAP
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2023
• Report Date (Section F): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SXMD1B406
• Device Lot Number: C601HAP
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 57 YR
• Patient Sex: Female