MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP N/A VUPD1214CE manufactured by Bard Access Systems.
[138913649]
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
[138913650]
Nurse called the advice line as she and the patient were concerned about the picc line. On speaking to the nurse she reports there have been ongoing issues with the patient reacting to the statlock dressing, in which her skin becomes very red and crusty and the dressing, and picc line itself, move as a result of this. No other information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00536 |
| MDR Report Key | 8415001 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-12 |
| 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 | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| 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 | 0 |
| Brand Name | STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | FOX |
| Date Received | 2019-03-12 |
| Model Number | N/A |
| Catalog Number | VUPD1214CE |
| 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 | 2019-03-12 |