MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-24 for * 69979-87 TM KC 200 manufactured by Kimberly-clark.
[3265634]
A nurse tried to put on isolation gown to enter a room and found the elastic at the wrist was not secured, so the sleeve was not tight to her arm. ======================manufacturer response for isolation gown, kimberly clark isolation gown (per site reporter). ======================e-mail to company rep not yet responded to. What was the original intended procedure? Protect staff from exposure to infectious agents from patients in isolation room. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3082101 |
| MDR Report Key | 3082101 |
| Date Received | 2013-04-24 |
| Date of Report | 2013-04-24 |
| Date of Event | 2013-04-17 |
| Report Date | 2013-04-24 |
| Date Reported to FDA | 2013-04-24 |
| Date Reported to Mfgr | 2013-04-29 |
| Date Added to Maude | 2013-04-29 |
| 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 | 2013-04-24 |
| Model Number | 69979-87 |
| Catalog Number | TM KC 200 |
| Lot Number | LG 3 017 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2013-04-24 |