MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-07 for DRY GAUZE PREOPERATIVE SKIN PREP TRAY * 4437 manufactured by Carefusion Corp.
[15424026]
Reporting voluntary as a pt safety concern. In the dry gauze preoperative skin prep trays there are yellow sponge sticks that are used for vaginal preps in operating room. These sponge sticks are designed with a slit in the top. What operating room staff and surgeons are concerned with is when the sponge is inserted into the vaginal cavity that the sponge pushes back exposing the plastic stick and this has been reported to cause abrasions or lacerations. It was reported that these types of events have occurred in the past. Operating room staff stated that a laceration occurred to this pt with this sponge stick, but was unable to find any documentation. Pt went home same day as surgery. Surgeons and the operating room staff are voicing concerns with the design of this device related to pt safety.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028253 |
| MDR Report Key | 2883930 |
| Date Received | 2012-12-07 |
| Date of Report | 2012-12-05 |
| Date of Event | 2012-11-27 |
| Date Added to Maude | 2012-12-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRY GAUZE PREOPERATIVE SKIN PREP TRAY |
| Generic Name | DRY GAUZE PREOPERATIVE SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2012-12-07 |
| Model Number | * |
| Catalog Number | 4437 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION CORP |
| Manufacturer Address | 3750 TORREY VIEW CT. SAN DIEGO CA 92130 US 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-07 |