MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-20 for COMFORT PERSONAL CLEANSING BATH CLOTHS 7989 manufactured by Sage Products.
[17527960]
During a patient prep, the sage product was removed from the warmer and when the "peel here" tab was pulled back to expose the towelettes, glass shards were found attached to the adhesive. This happened with the same product/lot number and two different packages/occurrences. In one occurrence, due to the presence of the glass, the nurse opening the packaging cut herself and bled. The entire lot was removed from the warmers and shelves and quarantined per hospital protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016819 |
| MDR Report Key | 1770427 |
| Date Received | 2010-07-20 |
| Date of Report | 2010-07-20 |
| Date of Event | 2010-07-19 |
| Date Added to Maude | 2010-07-29 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT PERSONAL CLEANSING BATH CLOTHS |
| Generic Name | DISPOSABLE CLEANSING BATH CLOTHS |
| Product Code | NSB |
| Date Received | 2010-07-20 |
| Catalog Number | 7989 |
| Lot Number | 20808/2/1B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-20 |