MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-13 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[100264763]
The product is supplied with the expiration date clearly labeled. The device expired in 6/2016. A review of records shows that the device was supplied to the user facility in 2014. This event is confirmed for use related. The ifu instructs the user "do not use progel? Pals after the expiration date, because sterility or performance may be compromised. " the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Used on patient.
Patient Sequence No: 1, Text Type: N, H10
[100264764]
It was reported that an expired progel sealant was used on a patient. Following the initial application, the progel did not work. The surgeon was told the product was expired. The physician asked for a second sealant, floseal, to complete the procedure. No other intervention was rendered except for the application of floseal. The patient was reported as doing fine and not having any problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-00253 |
| MDR Report Key | 7266033 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-13 |
| Date of Report | 2018-02-13 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2018-02-13 |
| 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 |
| 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 |
| Brand Name | PROGEL PLUERAL AIR LEAK SEALANT |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2018-02-13 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 141016-007 |
| Device Expiration Date | 2016-06-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |