MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for OR STERILE TOWEL manufactured by Allcare, Inc..
[139421923]
There was excessive lint coming off of the sterile towels. The surgical site had to be washed off and re-prepped. This has been investigated by our infection prevention team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8439290 |
| MDR Report Key | 8439290 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-01 |
| Report Date | 2019-03-13 |
| Date Reported to FDA | 2019-03-13 |
| Date Reported to Mfgr | 2019-03-21 |
| Date Added to Maude | 2019-03-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OR STERILE TOWEL |
| Generic Name | ACCESSORY, SURGICAL APPAREL |
| Product Code | LYU |
| Date Received | 2019-03-21 |
| Lot Number | 11RI14 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLCARE, INC. |
| Manufacturer Address | 2580 FOXFIELD RD STE 101 ST CHARLES IL 60174 US 60174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |