MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for 07-CA601 manufactured by Advance Medical Designs, Inc..
[127886090]
The unopened c-drape had a long black hair in it. The package was still sealed. Luckily, the surgical technician saw the hair before she opened the package and the sterile field was not compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8089046 |
| MDR Report Key | 8089046 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-11-09 |
| Report Date | 2018-11-13 |
| Date Reported to FDA | 2018-11-13 |
| Date Reported to Mfgr | 2018-11-20 |
| Date Added to Maude | 2018-11-20 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | SYSTEM, DRAPE, X-RAY |
| Product Code | KKX |
| Date Received | 2018-11-20 |
| Model Number | 07-CA601 |
| Catalog Number | 07-CA601 |
| Lot Number | 80647C8150 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCE MEDICAL DESIGNS, INC. |
| Manufacturer Address | 1241 ATLANTA INDUSTRIAL DRIVE MARIETTA GA 30066 US 30066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |