MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-18 for ISOLATION GOWN KC200 69979 manufactured by Kimberly-clark Corporation.
[21988208]
New package of isolation gowns found to have sleeves sealed shut and seams not sealed. Unable to use them for protection of staff going into isolation rooms. No staff used a defective gown, but potential for exposure is high if staff not aware that seams are open. Seems to be an intermittent problem as this occurred in the fall of 2011 and again in the spring of 2012. ======================manufacturer response for isolation gowns, isolation gown (per site reporter). ======================no response yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2897200 |
| MDR Report Key | 2897200 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-12-10 |
| Report Date | 2012-12-18 |
| Date Reported to FDA | 2012-12-18 |
| Date Added to Maude | 2013-01-04 |
| 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 | 3 |
| 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 | ISOLATION GOWN |
| Generic Name | GOWN, ISOLATION, SURGICAL |
| Product Code | FYC |
| Date Received | 2012-12-18 |
| Model Number | KC200 |
| Catalog Number | 69979 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL, GA 30076 GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-18 |