MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for DALE TRACHEOSTOMY TUBE HOLDER (TIE) manufactured by Dale Medical Products Inc..
[161003496]
Dale trach collar - one of the velcro pieces popped off. This is dangerous for the pt's ability to breathe. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5090128 |
| MDR Report Key | 9145138 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-09-27 |
| Date of Event | 2019-09-25 |
| Date Added to Maude | 2019-10-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DALE TRACHEOSTOMY TUBE HOLDER (TIE) |
| Generic Name | DEVICE, FIXATION, TRACHEAL TUBE |
| Product Code | CBH |
| Date Received | 2019-10-01 |
| Lot Number | 18K3158 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DALE MEDICAL PRODUCTS INC. |
| Manufacturer Address | FRANKLIN LAKES NJ 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-01 |