MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	440123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/13/2010
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title: randomised controlled study of two different techniques of skin suture in endoscopic release of carpal tunnel source: department of orthopaedics, section of hand surgery, orthopaedic research unit, regional hospital holstebro, holstebro,denmark date: 2009.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pli10: according to literature source of study performed between october 2006 and april 2007, in a prospective, randomised trial of 54 hands in 47 patients incisions were randomised to be closed by either absorbable subcuticular or non-absorbable interrupted sutures after single portal endoscopic release of the carpal tunnel.Twenty-eight hands were available for follow up for absorbable subcuticular suture group compared to the group who received non-absorbable interrupted suture.One patient from each group had inflammation of the wound during the first 14 days after the operation, but the symptoms resolved and at 3 months visit, there were no other complications.Pli20: according to literature source of study performed between october 2006 and april 2007, in a prospective, randomised trial of 54 hands in 47 patients incisions were randomised to be closed by either absorbable subcuticular or non-absorbable interrupted sutures after single portal endoscopic release of the carpal tunnel.Twenty-eight hands were available for follow up for absorbable subcuticular suture group compared to the group who received non-absorbable interrupted suture.One patient from each group had inflammation of the wound during the first 14 days after the operation, but the symptoms resolved and at 3 months visit, there were no other complications.Article: torben bæk hansen, lone kirkeby, heidi fisker & kristian larsen, 2009, randomised controlled study of two different techniques of skin suture in endoscopic release of carpal tunnel.

• Brand Name: NOVAFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8392507
• Report Number: 9612501-2019-00429
• Device Sequence Number: 11120751
• Product Code: GAT
• UDI-Device Identifier: 10884521118348
• UDI-Public: 10884521118348
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 440123
• Device Catalogue Number: 440123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR