MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for SURGICAL PACK CDVS22E manufactured by American Contract Systems, Inc..
[119348019]
Opening up the sterile pack and there was a hair in the blue basin. The back table and supplies were wasted. This delayed the case by about 10 minutes. The pack was removed. The pack was made by (b)(4). New setup completed and procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7850173 |
| MDR Report Key | 7850173 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-24 |
| Date of Event | 2018-08-24 |
| Report Date | 2018-08-24 |
| Date Reported to FDA | 2018-08-24 |
| Date Reported to Mfgr | 2018-09-06 |
| Date Added to Maude | 2018-09-06 |
| 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 | 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 | SURGICAL PACK |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | LRP |
| Date Received | 2018-09-06 |
| Catalog Number | CDVS22E |
| Lot Number | 834181 |
| 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 | 2018-09-06 |