MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-14 for STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST N/A PIC0222 manufactured by Bard Access Systems.
[138811806]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[138811807]
It was reported the patient reacted vigorously to the pad/adhesive part of a statlock device. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00575 |
| MDR Report Key | 8421215 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-14 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | DAVOL SURGICAL INNOVATIONS -9616067 |
| Manufacturer Street | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO |
| Manufacturer City | CD. JUAREZ, CHIH S.A. DE C.V. 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | FOX |
| Date Received | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | PIC0222 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-14 |