MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for KITTNER (BLUNT) DISSECTOR 30-101 manufactured by Deroyal Industries, Inc..
[55232394]
Patient Sequence No: 1, Text Type: N, H10
[55232395]
Surgeon noted radiopaque thread shredding from kittner sponge when in use. Note: request made for company rep contact information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5966055 |
| MDR Report Key | 5966055 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-09-06 |
| Report Date | 2016-09-07 |
| Date Reported to FDA | 2016-09-07 |
| Date Reported to Mfgr | 2016-09-07 |
| Date Added to Maude | 2016-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | KITTNER (BLUNT) DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC |
| Product Code | EFQ |
| Date Received | 2016-09-21 |
| Model Number | 30-101 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LN. POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |