MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	CP-424
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2018
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, during hernia procedure, while the doctor was fixing the mesh with the suture and anchoring, the thread broke.The suture was treated or hydrated prior to use with serum and normal suturing technique was employed by the surgeon.The device component fell into the patient's cavity and was not retrieved.Replaced by another suture to complete the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hernia procedure, while the doctor was fixing the mesh with the suture and anchoring, the thread broke.The suture was treated or hydrated prior to use with serum and normal suturing technique was employed by the surgeon.The thread fell into the patient's cavity when the doctor was knotting the sutures and was not retrieved.Replaced by another suture to complete the case.

• Brand Name: SURGIPRO
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7498756
• Report Number: 9612501-2018-00953
• Device Sequence Number: 2222535
• Product Code: GAW
• UDI-Device Identifier: 20884521036229
• UDI-Public: 20884521036229
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K954808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 12/31/2021
• Device Model Number: CP-424
• Device Catalogue Number: CP-424
• Device Lot Number: D6M0214X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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: 27 YR
• Patient Weight: 28