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 |