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..
[131712892]
As reported, the progel sealant was applied and performed as intended. Based on the information provided, it is unknown why the user felt the product was "runny". No definitive conclusions can be made regarding the surgeons report of the difference in the consistency of the product. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Used on patient and discarded.
Patient Sequence No: 1, Text Type: N, H10
[131712893]
It was reported that the user of the progel felt the product was? Runny? During a lobectomy. The initial repair was performed with staples. The preparation of the progel was performed according to the instructions for use and no problems presented in set up. The progel was applied both as a stream and spray and was used to effectively complete the case. There was no patient injury/harm reported. The product was reported to be stored appropriately prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2018-04954 |
| MDR Report Key | 8202732 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2018-09-27 |
| 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 | 170621-005 |
| 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 | 2018-12-28 |