MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for ACS CDMH06E manufactured by American Contract Systems, Inc..
[134885260]
A hair was found on the plastic blue basin in the anterior hip pack (cdmh06e) prior to the patient entering the operating room. The basin and supplies were thrown away and a new sterile field was set up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8300775 |
| MDR Report Key | 8300775 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-31 |
| Report Date | 2019-01-31 |
| Date Reported to FDA | 2019-01-31 |
| Date Reported to Mfgr | 2019-02-04 |
| Date Added to Maude | 2019-02-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ACS |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | LRP |
| Date Received | 2019-02-04 |
| Model Number | CDMH06E |
| Lot Number | 654181 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN CONTRACT SYSTEMS, INC. |
| Manufacturer Address | 904 BETHEL CIRCLE WAUNAKEE WI 53597 US 53597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |