MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-07-25 for PROGEL PALS PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[80956339]
This initial mdr is being submitted as a result of a retrospective review of davol? S mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures. The subject product was returned for evaluation. No crosslinked gel was inside the spray tip, indicating gel was not expressed through the spray tip. Very little gel was noticed inside the applicator housing. Both cartridges were broken at the proximal end. The face of the crimped caps (which are pressed into the inside of the applicator), were both dented, which indicates excessive force was applied to the cartridges. A dimensional inspection of the returned components did not find any anomalies. A review of the manufacturing records for the reported product code and lot number revealed that there were no discrepancies during manufacture. There are various causes that can contribute to the reported failure mode. Based on the available information and sample evaluation, root cause cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[80956340]
Addendum per follow up with contact (report): per the or nurse, the affected progel applicator was removed from the surgical field and a new assembly and a new progel applicator was used to complete the case. As reported, there were no adverse outcomes from the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00440 |
| MDR Report Key | 6741541 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-09-21 |
| Date Added to Maude | 2017-07-25 |
| 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 | ANDREW TOPOULOS |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258495 |
| 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 PALS |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2017-07-25 |
| Returned To Mfg | 2015-11-10 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 150610-001 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |