MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GM-121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Paralysis (1997); Sepsis (2067); Peritonitis (2252); No Code Available (3191)
Date of Event	10/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, five days following an open end-to-end ileoileostomy with small intestine segment resection for an obstructive ileus, the patient had an anastomosis insufficiency with regular blood circulation, intestinal paralysis, increase in inflammatory signs and peritonitis.Re-laparotomy sufficiency, resection of anastomosis and ileostomy were done to complete the case.This resulted in a 14-day extension of patient's hospitalization for sepsis therapy.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 9320811
• Report Number: 9612501-2019-02204
• Device Sequence Number: 16737641
• Product Code: GAM
• UDI-Device Identifier: 10884521032415
• UDI-Public: 10884521032415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GM-121
• Device Catalogue Number: GM-121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 76