MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-12 for PROTECTION PLUS AIRSTREAM/BREATHABLE UNDERPAD MSC282110 manufactured by Medline Industries, Inc..
[582278]
Nurse opened the medline protection plus airstream/breathable underpad, which is vacuum packed. When the pack opened, particles of the absorbent flew into the air which got into the nurse's eyes as well as was inhaled. Further analysis of this event revealed the following: after opening the package, it is necessary to unfold each pad before use. If you take the time to pull the folds out slowly and gently, the pad seems fine. If instead, you snap it out quickly to open the folds, the seal around the underpad will break. After the seal is compromised, the pad will separate and all of the absorbent material will become airborne. The absorbent will break apart into several clumps, as well as thousands of very fine particles, which will float into the air. This is not only an eye irritant, but also represents a much worse respiratory hazard for both the healthcare worker and patients. These particular pads are currently being removed from our facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 808277 |
| MDR Report Key | 808277 |
| Date Received | 2007-01-12 |
| Date of Report | 2007-01-12 |
| Date of Event | 2007-01-10 |
| Report Date | 2007-01-12 |
| Date Reported to FDA | 2007-01-12 |
| Date Added to Maude | 2007-01-25 |
| 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 |
| 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 | PROTECTION PLUS AIRSTREAM/BREATHABLE UNDERPAD |
| Generic Name | UNDERPAD, PROTECTION |
| Product Code | LWG |
| Date Received | 2007-01-12 |
| Model Number | MSC282110 |
| Catalog Number | MSC282110 |
| Lot Number | NA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 795762 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 NORTHPOINT BLVD. WAUKEGAN IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-12 |