MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-21 for BBRAUN/AESCULAP SCALPFIX FF013P D4038653342679 manufactured by Aesculap Ag / Germany.
[3586764]
Raney clip retained inside pt during surgery; resulted in add'l surgery for pt for removal. Unable to count raney clips according to aorn recommended practices because of the product packaging. It is impossible to complete an accurate initial count because the packaging does not allow for visibility of all of the clips before opening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031586 |
| MDR Report Key | 3308645 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-02-07 |
| Date Added to Maude | 2013-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBRAUN/AESCULAP SCALPFIX |
| Generic Name | BBRAUN/AESCULAP SCALPFIX |
| Product Code | HBO |
| Date Received | 2013-08-21 |
| Model Number | FF013P |
| Catalog Number | D4038653342679 |
| Lot Number | S1906795 |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG / GERMANY |
| Manufacturer Address | TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-08-21 |