MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-11 for PELVILACE? BIOURETHRAL SUPPORT SYSTEM 482150 manufactured by C.r. Bard, Inc. (covington) -1018233.
[74938787]
May 2017 bimonthly asr report. (b)(4). The total number of events for product classification code pag is (b)(6). Qty 9- pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1. 5 cm x 50 cm porcine acellular collagen matrix sling qty 2- pelvilace to biourethral support system qty 1- pelvilace to biourethral support system needle and implant hook needle 50 cm - 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. Sample not returned.
Patient Sequence No: 1, Text Type: N, H10
[74938788]
May 2017 bimonthly asr report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-02366 |
| MDR Report Key | 6559911 |
| Report Source | OTHER |
| Date Received | 2017-05-11 |
| Date of Report | 2019-01-11 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2017-05-11 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGELA ROBINSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD UNIT 1 |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELVILACE? BIOURETHRAL SUPPORT SYSTEM |
| Generic Name | PELVILACE? BIOURETHRAL SUPPORT SYSTEM |
| Product Code | PAG |
| Date Received | 2017-05-11 |
| Catalog Number | 482150 |
| Lot Number | CVPB0005 |
| Device Expiration Date | 2006-09-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD UNIT 1 COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-11 |