MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[131598440]
As reported, the progel was applied as a secondary closure and no submersion was performed to identify if a leak was present at the time of application. Based on the information provided, the source of the air leak that presented cannot be determined. A review of the manufacturing records was performed and found that the lot was manufactured to specification. No definitive conclusions can be made regarding the surgeons report of a difference in the consistency of the product and if the progel contributed to the air leak that presented. The ifu for the progel product instructs: allow the progel? Pals to cure for 15-30 seconds, forming a flexible hydrogel. Two minutes after application, the sealant? S success in sealing the target site(s) can be tested using a submersion test or by irrigating the site to check for air bubbles. Pulmonary air leak is listed as one of the potential adverse effects associated with the device. Discarded by user facility.
Patient Sequence No: 1, Text Type: N, H10
[131598441]
It was reported that during a decortication, progel was applied to the area as secondary closure, and a difference in the consistency of the product was noted. The surgeon felt that when used, it clumped up a bit and didn? T seal the lung effectively. The patient experienced an air leak and was kept in the hospital until it resolved. There was no submersion performed to identify if a leak was present at the time of application of the progel. No intervention was required and the leak resolved on its own without treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-04953 |
| MDR Report Key | 8202501 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2018-09-04 |
| Date Added to Maude | 2018-12-28 |
| 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 |
| Brand Name | PROGEL PLUERAL AIR LEAK SEALANT |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2018-12-28 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 170621-004 |
| Device Expiration Date | 2019-06-13 |
| 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 | 1. Hospitalization | 2018-12-28 |