MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-07-28 for PROGEL PALS PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[81260133]
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 not returned for evaluation. The review of the dhr did not show any deviations or nonconformances that could have led to this event. Label reconciliation shows that only the 130513-002 labels with an expiration date of jan-2015 were used in the production lot. Based on the limited information provided, no connection can be made between the reported event and the davol product in question. 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. Discarded.
Patient Sequence No: 1, Text Type: N, H10
[81260134]
Contact reports that the expiration date on the progel outer carton is different than the inner package. Requested to know if this is correct and which would be the date to go by. Contact informed that product should contain a lot number and expiration date that is the same at each level of packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00469 |
| MDR Report Key | 6750117 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-07-28 |
| Date of Report | 2017-11-22 |
| Date Mfgr Received | 2017-11-22 |
| Device Manufacturer Date | 2013-05-13 |
| Date Added to Maude | 2017-07-28 |
| 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 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGEL PALS |
| Generic Name | PROGEL PALS, 4ML, US |
| Product Code | NBE |
| Date Received | 2017-07-28 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 130513-002 |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-07-28 |