MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	S-316
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, postoperative from a scrotal procedure, the midline scrotal incision looks good though the upper 1 -1.5 cm wound had opened up.It was stated that it looked like the sutures have already absorbed in this region.There was no drainage, erythemia or significant swelling noted.A topical skin adhesive was applied over this upper part of the incision with good results.The patient tolerated this without issue.There was no patient injury.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8398549
• Report Number: 9612501-2019-00452
• Device Sequence Number: 10841072
• Product Code: GAP
• UDI-Device Identifier: 10884521086494
• UDI-Public: 10884521086494
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-316
• Device Catalogue Number: S-316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1