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

Model Number	SL-690
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Injury (2348); No Code Available (3191)
Date of Event	11/10/2018
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, on (b)(6) 2018, under local anesthesia, the patient underwent debridement and suture of soft tissue contusion and laceration on the back of the right foot and long and short extensor tendon rupture and anastomosis of great toe, with absorbable surgical suture to suture tendon and non absorbable polyester suture to suture the skin.On (b)(6) 2018, the patient's wound was removed and discharged.After discharge, it was found that the tendon suture was gradually discharged from the body, which affected the life of the patient.The patient came to the hospital for further consultation on (b)(6) 2019.The suture of tendon was removed.There was rejection due to the patient's physical condition.No other devices were used in combination.There was patient injury.

• 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: 9463630
• Report Number: 9612501-2019-02413
• Device Sequence Number: 3066432
• Product Code: GAM
• UDI-Device Identifier: 10884521049192
• UDI-Public: 10884521049192
• 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): 12/12/2019

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: 10/31/2019
• Device Model Number: SL-690
• Device Catalogue Number: SL-690
• Device Lot Number: D4K0280X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/12/2019
• 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; Other
• Patient Age: 51 YR