MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-25 for * 69979-87 TM KC 200 manufactured by Kimberly-clark.
[20010552]
A nurse put an isolation gown on prior to entering the room where the patient was in transmission based precautions. There were no ties on gown to keep it closed. ======================manufacturer response for isolation gown, kimberly clark isolation gown (per site reporter). ======================e-mail to company rep. Have had no reply from any of the notices sent this week. What was the original intended procedure? Protect staff from exposure to infectious agents from patients in isolation rooms. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3086904 |
| MDR Report Key | 3086904 |
| Date Received | 2013-04-25 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-24 |
| Report Date | 2013-04-25 |
| Date Reported to FDA | 2013-04-25 |
| Date Reported to Mfgr | 2013-05-01 |
| Date Added to Maude | 2013-05-01 |
| 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 | * |
| Generic Name | GOWN, ISOLATION |
| Product Code | FYC |
| Date Received | 2013-04-25 |
| Model Number | 69979-87 |
| Catalog Number | TM KC 200 |
| Lot Number | LB 3 078 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-25 |