PROGEL PLUERAL AIR LEAK SEALANT PGSSS008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-08-28 for PROGEL PLUERAL AIR LEAK SEALANT PGSSS008 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

MAUDE Entry Details

• Report Number: 1213643-2019-07829
• MDR Report Key: 8941034
• Report Source: FOREIGN,USER FACILITY
• Date Received: 2019-08-28
• Date of Report: 2019-09-16
• Date of Event: 2019-08-07
• Date Mfgr Received: 2019-08-29
• Device Manufacturer Date: 2019-04-26
• Date Added to Maude: 2019-08-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ANNA SMITH
• Manufacturer Street: 100 CROSSINGS BLVD.
• Manufacturer City: WARWICK RI 02886
• Manufacturer Country: US
• Manufacturer Postal: 02886
• Manufacturer Phone: 4018258449
• Manufacturer G1: NEOMEND INC -2953195
• Manufacturer Street: 60 TECHNOLOGY DRIVE
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal Code: 92618
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROGEL PLUERAL AIR LEAK SEALANT
• Generic Name: SEALANT, POLYMERIZING
• Product Code: NBE
• Date Received: 2019-08-28
• Returned To Mfg: 2019-08-29
• Model Number: NA
• Catalog Number: PGSSS008
• Lot Number: IRDQ0023
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DAVOL INC., SUB. C.R. BARD, INC.
• Manufacturer Address: 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-28