MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for STERILE DISPOSABLE TOWELS MDT2168904 manufactured by Medline Industries.
[104211369]
Excessive lint is found coming off the towels during cardiac cath. The lint adheres to gloves and wires placing a risk to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076245 |
| MDR Report Key | 7388047 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-23 |
| Date Added to Maude | 2018-04-02 |
| 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 | 0 |
| Brand Name | STERILE DISPOSABLE TOWELS |
| Generic Name | STERILE DISPOSABLE TOWELS |
| Product Code | FRL |
| Date Received | 2018-03-30 |
| Model Number | MDT2168904 |
| Lot Number | 27916090003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-30 |