MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for VYGON 5804.08 manufactured by Tidi Products, Llc.
[106388169]
Product was not available for return to tidi for evaluation. Report is based on medwatch submitted by user facility, (b)(4). Customer admitted to applying the device too tightly causing bruising to patient. At this time there is no evidence that a manufacturing nonconformity contributed to the reported complaint. The instructions for use were reviewed and provided adequate instructions for effective use of the device. Manufacturer reference file number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106388170]
Customer reported that "dark discoloration noted on right lower leg after picc removal, under the stabilizer"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00001 |
| MDR Report Key | 7456891 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-01-03 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2017-06-26 |
| Date Added to Maude | 2018-04-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JACKIE KRIEGLSTEIN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VYGON |
| Generic Name | PICC (AND STABILIZER) |
| Product Code | KMK |
| Date Received | 2018-04-24 |
| Model Number | 5804.08 |
| Lot Number | 28853245 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 570 ENTERPRISE DR NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-24 |