MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for GRIP-LOK 3300M manufactured by Tidi Products Llc.
[112995237]
Product request for return but will not be returned because it was disposed of this complaint is based solely on customer reported issue and is under investigation at this time there is not sufficient information to suggest that this is a manufacturing nonconformity. Manufacture reference #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112995238]
Customer reported reaction 2-5 days after application of new device. Reaction described as itchy red rash at contact points with device. Symptoms improved with removal. Doctor shared suspicion that patient has undiagnosed allergy. No further information provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[129957134]
Evaluation results: additional information received from the physician, indicated the patient has an undiagnosed allergy to acrylic. Biocompatibility results for the securement device found sensitivity levels to skin contact, to be negligible. A review of the historical complaint database for similar events found this is the first complaint of this type. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the 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. Manufacturer reference file #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129957135]
Supplemental mdr required for investigation results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00004 |
| MDR Report Key | 7657307 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-07-02 |
| 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 | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514009 |
| Manufacturer G1 | TIDI PRODUCTS LLC |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54956 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GRIP-LOK |
| Generic Name | UNIVERSAL SECUREMENT DEVICE |
| Product Code | KMK |
| Date Received | 2018-07-02 |
| Model Number | 3300M |
| Lot Number | 25738623 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Other | 2018-07-02 |