MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-05 for SURGIPRO II * VP-706-X manufactured by Covidien.
[4879443]
A suture pack that was opened and placed on the back table was noted to have a fine hair inside the packaging. The back table was taken down and supplies replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4029730 |
| MDR Report Key | 4029730 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-08-05 |
| Date of Event | 2014-07-25 |
| Report Date | 2014-08-05 |
| Date Reported to FDA | 2014-08-05 |
| Date Reported to Mfgr | 2014-08-22 |
| Date Added to Maude | 2014-08-22 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIPRO II |
| Generic Name | SUTURE |
| Product Code | GAS |
| Date Received | 2014-08-05 |
| Model Number | * |
| Catalog Number | VP-706-X |
| Lot Number | D4C1706X |
| ID Number | * |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-05 |