MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-18 for UNK 235 manufactured by Busse Hospital Disposables.
[20715044]
Received personal protection gown from (b)(6). Prior to use - gown was noted to have what appeared to be blood on it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3111950 |
| MDR Report Key | 3111950 |
| Date Received | 2013-03-18 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-03-30 |
| Date Facility Aware | 2012-03-30 |
| Report Date | 2012-05-10 |
| Date Reported to Mfgr | 2012-05-10 |
| Date Added to Maude | 2013-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | PERSONAL PROTECTION GOWN |
| Product Code | FYC |
| Date Received | 2013-03-18 |
| Catalog Number | 235 |
| Lot Number | 67429 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUSSE HOSPITAL DISPOSABLES |
| Manufacturer Address | HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-18 |