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

Model Number	VPG56SE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
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 surveys for wound closure, two patients had minimal acute inflammatory reaction due to the device.The localized inflammation was resolved after five days.

• Brand Name: PTFE POLYMER PLEDGETS
• 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: 8893310
• Report Number: 9612501-2019-01554
• Device Sequence Number: 16208053
• Product Code: GAT
• UDI-Device Identifier: 10884521550711
• UDI-Public: 10884521550711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K930591
• 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
• Report Date (Section B): 08/14/2019

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 Model Number: VPG56SE
• Device Catalogue Number: VPG56SE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/14/2019
• 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