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

Model Number	CL-977
Medical Device Problem Codes	Unraveled Material (1664); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Date of Event	08/06/2019
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, the patient undergo a transabdominal hysterectomy procedure, to intermittently suture the fat layer with synthetic absorbable surgical sutures.Third day post-operatively, the incision had a little exudate, no chills, no fever or no abdominal pain and no abnormalities were found in the routine blood test.But it was reported that the absorption of the suture was slower leading to poor wound healing.And on seventh day post-operatively the incision was split about 8 cm deep to reach the fat layer, and the absorbable suture could be seen.To resolve the issue the suture immediately removed and had to re-suture the patient.Other treatment was taken by intravenous infusion of 0.9% sodium chloride injection 100ml and cefotiam 2.0g to prevent infection.The incision was given a specific electromagnetic wave therapeutic device, and thermal irradiation and enhanced dressing treatment.

• 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: 9444329
• Report Number: 9612501-2019-02373
• Device Sequence Number: 14008117
• Product Code: GAM
• UDI-Device Identifier: 10884521044241
• UDI-Public: 10884521044241
• 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): 12/10/2019

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 Expiration Date: 11/30/2023
• Device Model Number: CL-977
• Device Catalogue Number: CL-977
• Device Lot Number: D8M0217FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/10/2019
• 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: Required Intervention
• Patient Age: 46 YR