MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-10-14 for GRIP-LOK 3300MWA-NSB manufactured by Tidi Products, Llc.
[123670872]
Product requested for return but will not be returned. No evidence was provided. This complaint is based solely on customer reported issue. Adhesive supplier was contacted, there have been no changes in product formulations. There is not enough evidence to establish the root cause of the skin irritation and redness. Biocompatibility results for this securement device found sensitivity levels for skin contact to be negligible. Instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123670873]
Customer reported itching and redness on the skin of patient. The date of the incident is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00016 |
| MDR Report Key | 7963862 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-10-14 |
| Date of Report | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2016-06-16 |
| Date Added to Maude | 2018-10-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE VERCAUTEREN |
| 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 WIDE ADHESIVE BULK NON-STERILE |
| Product Code | KMK |
| Date Received | 2018-10-14 |
| Model Number | 3300MWA-NSB |
| Catalog Number | 3300MWA-NSB |
| Lot Number | 24950354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-14 |