MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for AESCULAP FF013P manufactured by Aesculap Ag.
[99119653]
Patient Sequence No: 1, Text Type: N, H10
[99119654]
Scalpfix loads for this lot number do not work properly. A different lot number of same product was opened to complete the case. Manufacturer response for scalp clip, (brand not provided) (per site reporter). On-line complaint form was filled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7244079 |
| MDR Report Key | 7244079 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-11-15 |
| Report Date | 2018-01-03 |
| Date Reported to FDA | 2018-01-03 |
| Date Reported to Mfgr | 2018-01-03 |
| Date Added to Maude | 2018-02-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | AESCULAP |
| Generic Name | CLIP, SCALP |
| Product Code | HBO |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2017-12-13 |
| Catalog Number | FF013P |
| Lot Number | 52336428 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | 3773 CORPORATE PKWY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |