MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-28 for PREP SPONGE STICK 2 X 2 X 1, 8" manufactured by Seamless Professional Medical Products, Inc..
[19240089]
Yellow prep sponge retained in vagina after sponge slipped off stick. Other prep sponges from this mfr were examined and found to be loose on stick and easily slipped off. Pt presented to physician on 12/12/94 with retained sponge. Sponge removed without injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004584 |
| MDR Report Key | 18558 |
| Date Received | 1994-12-28 |
| Date of Report | 1994-12-14 |
| Date of Event | 1994-10-17 |
| Date Added to Maude | 1994-12-29 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREP SPONGE STICK 2 X 2 X 1, 8" |
| Generic Name | PREP SPONGE STICK |
| Product Code | HGD |
| Date Received | 1994-12-28 |
| Lot Number | 44082392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18486 |
| Manufacturer | SEAMLESS PROFESSIONAL MEDICAL PRODUCTS, INC. |
| Manufacturer Address | OCALA FL 32670 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-12-28 |