MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for SPECIALIST 100 COTTON STERILE CAST PADDING 9086S 72346-03 manufactured by Bsn Medical, Inc..
[80891486]
Patient Sequence No: 1, Text Type: N, H10
[80891487]
In the operating room (o. R), the sterile packaging for the product listed was opened onto a sterile field. After opening the packaging, an insect (identified by staff as a mosquito) was found in the padding material of the product. The item was removed from the o. R and the sterile field was taken down and a new field set up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6739679 |
| MDR Report Key | 6739679 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-27 |
| Report Date | 2017-07-20 |
| Date Reported to FDA | 2017-07-20 |
| Date Reported to Mfgr | 2017-07-20 |
| Date Added to Maude | 2017-07-25 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECIALIST 100 COTTON STERILE CAST PADDING |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2017-07-25 |
| Model Number | 9086S |
| Catalog Number | 72346-03 |
| Lot Number | 357670 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL, INC. |
| Manufacturer Address | 1555 4TH AVE. SE HICKORY NC 28602 US 28602 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |