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

Model Number	CL-977
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Pain (1994); Swelling (2091); Impaired Healing (2378); No Code Available (3191)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient was hospitalized with right lower abdominal pain for 2 days.The admitting diagnosis was acute appendicitis with peritonitis.The patient was sent to the operating room for laparoscopic exploration under anesthesia under tracheal intubation, transitive colonic bowel resection and single cavity ostomy.The procedure was smooth, and the incision was red, swollen, painful, and exuded.The incision site was debrided and reclosed.They gave cleaned unabsorbed thread, cleaned the incision, prolonged the application of antibiotics, intravenous drip 0.9% ns100ml with cefoperazone sodium, tazobactam sodium 2.0g.The intravenous drip was given but the antibiotics application was extended.The dressing was changed.

• Brand Name: POLYSORB
• 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: 10173425
• Report Number: 9612501-2020-00880
• Device Sequence Number: 17022667
• Product Code: GAM
• UDI-Device Identifier: 20884521044248
• UDI-Public: 20884521044248
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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 Expiration Date: 10/31/2022
• Device Model Number: CL-977
• Device Catalogue Number: CL-977
• Device Lot Number: D7K2582FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/19/2020
• 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: 71 YR
• Patient Weight: 75