MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-22 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[63098378]
The progel was used to treat the patient and there was no immediate post-op complications reported and the patient was released in good condition. Progel? Pleural air leak sealant is a single use device intended for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma. Progel will support seal strength during initial postoperative period. A review of the manufacturing records for this product lot was performed and no anomalies were found. Based on the information provided the source of the air leak that presented 14 days post-op cannot be determined. At this time no definitive conclusions can be made. 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.
Patient Sequence No: 1, Text Type: N, H10
[63098379]
As reported on (b)(6) 2016 the patient underwent lobectomy that included use of progel sealant over the primary closure. On (b)(6) 2016 the patient was released home with no issues. On (b)(6) 2016 the patient came back into doctors office with delayed air leak. Patient presenting with pneumothorax on x-ray. A chest tube was placed in the or and the patient was managed very conservatively. On (b)(6) 2016 the chest tube was removed and on (b)(6) 2016 the patient was discharged and is reportedly doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00583 |
| MDR Report Key | 6198522 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-22 |
| Date of Report | 2018-12-26 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2016-12-22 |
| 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 | 2016-12-22 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 161019-001 |
| Device Expiration Date | 2017-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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; 2. Required No Informationntervention | 2016-12-22 |