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

Model Number	CL-977
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Necrosis (1971); Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	09/30/2020
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, after giving birth, the patient's side incision was sutured layer by layer with absorbable sutures and in tradermal sutures.During the hospitalization period, it was disinfected twice a day with iodophor and treated with far-infrared radiation twice a day.During the period, the parturient woman complained that the wound had foreign body sensation and pain was tolerable.On (b)(6) 2020, it was found that the lower end of the perineal side incision was split and there was exudation.It was seen that the absorbable sutures were exposed in strips, the knots were prominent, and the perineal incisions were not healed well.Debrided the necrosis on the surface of the perineal incision, removed the thread and knots and strengthen the perineal care.The medical intervention of debridement required the patient to undergo an additional surgical procedure.The patient's hospitalization was extended as a result of the complication.The incision healed on (b)(6) 2020.

• 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: 10815401
• Report Number: 9612501-2020-01693
• Device Sequence Number: 19314266
• 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): 11/10/2020

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: 05/31/2024
• Device Model Number: CL-977
• Device Catalogue Number: CL-977
• Device Lot Number: D9F0992FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/10/2020
• 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: 26 YR
• Patient Weight: 70