MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number SN-5699G

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a repair of heel laceration, the needle broke and disengaged into cavity while suturing a laceration on the patient's heel.The broken piece was not recovered.Surgical time was extended for more than 30 minutes and hospitalization was extended.The patient was transferred to another facility.

• Brand Name: MONOSOF
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 14168109
• MDR Text Key: 289756594
• Report Number: 9612501-2022-00623
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521079182
• UDI-Public: 10884521079182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Model Number: SN-5699G
• Device Catalogue Number: SN-5699G
• Device Lot Number: D1F2421FY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/21/2022
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 6 YR
• Patient Sex: Female