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

Model Number	CL-977
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	10/22/2021
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 had a caesarean section of the lower uterus under intra-spinal anesthesia.The incision was sutured layer by layer with absorbable sutures, and intradermal cosmetic suture.The dressing was changed every other day, and after 24 hours, the far-infrared radiation treatment was performed twice a day.Patient was checked on the 10th day post-operative and got discharged after.However, after 13 days post-operatively, the patient returned to the hospital.The incision was checked, and the left side had an about 1 centimeter dehiscence.The absorbable sutures were showed as strips, unabsorbed, and exposed.The incision site was cleaned, disinfected, and the unabsorbed sutures were cut off.On the 17th day, the patient had another follow-up and the incision was observed to healed well.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13093077
• Report Number: 9612501-2021-02156
• Device Sequence Number: 4268063
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

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: 08/31/2025
• Device Model Number: CL-977
• Device Catalogue Number: CL-977
• Device Lot Number: D0J1079FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/28/2021
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female