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

Model Number	CP-412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	06/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Surgical intervention, extended incision.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open ulcer resection procedure, the sutures kept breaking.The incision was extended more than 1 inch due to the issue and medical or surgical intervention was needed to prevent permanent impairment of function.The patient is alive with 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, per additional information received 3 days after an open ulcer resection procedure, 7 envelopes of sutures from the same lot breaking.There blood loss because the sutures were broken.

• 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: 6751020
• Report Number: 9612501-2017-05870
• Device Sequence Number: 1465159
• Product Code: GAW
• UDI-Device Identifier: 20884521036120
• UDI-Public: 20884521036120
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 10/20/2017

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: 11/30/2021
• Device Model Number: CP-412
• Device Catalogue Number: CP-412
• Device Lot Number: D6L2552X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: Other
• Patient Age: 49 YR