MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-25 for GRIP-LOK 3302MCS-MC manufactured by Tidi Products, Llc.
[121618074]
Device was discarded by customer and will not be returned for evaluation. A sample from current inventory was pulled and attempts to recreated the reported issue are under investigation. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use are being reviewed for adequate warnings on the proper use and application of the device. Manufacturer reference file (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[121618075]
Customer reported that sharp edge on product broke skin of patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00009 |
| MDR Report Key | 7906482 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-27 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-25 |
| 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 | 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 | 3 |
| Brand Name | GRIP-LOK |
| Generic Name | GRIP-LOK MEDIUM CS FOR MEDCOMP PRO-PICC |
| Product Code | KMK |
| Date Received | 2018-09-25 |
| Model Number | 3302MCS-MC |
| Catalog Number | 3302MCS-MC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |