MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON BIOSYN UD 4/0 18 P-13; SUTURE

Model Number SM5690

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

According to the reporter: the patient came back after reverse of vasectomy because the wound opened up.Patient already been discharged? yes.How was the wound closed after the dehiscence? (re-operation in the or, outpatient, in the office) two were reapproximated in clinical office using a chromic suture; others were told to apply steri-strips to aid with approximation; some were simply told apply polysporin and allow the wound to heal by secondary intention.What was used to close the wound after the dehiscence? see #5.How is the patient doing now? ok.Patient comorbidities no.

Manufacturer Narrative

(b)(4).

• Brand Name: BIOSYN UD 4/0 18 P-13
• Type of Device: SUTURE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4243892
• MDR Text Key: 4987712
• Report Number: 1219930-2014-01046
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SM5690
• Device Catalogue Number: SM5690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other