MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-01-13 for PELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE 482152 manufactured by C.r. Bard, Inc. (covington) -1018233.
[65114607]
January 2017 bimonthly asr report. (b)(4). The total number of events for product classification code pag is 22. Qty 15-pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1. 5cm x 50cm porcine acellular collagen matrix sling. Qty 2- pelvilace to biourethral support system needle and implant halo needle 50cm. Qty 5- pelvilace to biourethral support system needle and implant hook needle 50cm. 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
[65114608]
January 2017 bimonthly asr report.
Patient Sequence No: 1, Text Type: D, B5
[67963550]
(b)(4). Original reporting time frame november 1, 2016 to december 31, 2016 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
[99317062]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2017-00090 |
| MDR Report Key | 6248876 |
| Report Source | OTHER |
| Date Received | 2017-01-13 |
| Date of Report | 2017-08-30 |
| Date Mfgr Received | 2016-12-01 |
| Date Added to Maude | 2017-01-13 |
| 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 | TISSUE SCIENCE LABORATORIES -3004086170 |
| Manufacturer Street | ASTLEY LANE INDUSTRIAL ESTATE UNIT 1 |
| Manufacturer City | SWILLINGTON, LEEDS LS268XT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS26 8XT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE |
| Generic Name | PELVILACE? TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE |
| Product Code | PAG |
| Date Received | 2017-01-13 |
| Catalog Number | 482152 |
| Lot Number | CVRH0001 |
| Device Expiration Date | 2010-03-31 |
| 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 | 2017-01-13 |