MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-11 for * KC200 69979-87 manufactured by Kimberly Clark.
[3273738]
Two isolation gowns without elastic on cuff to hold tight to wrist. One of the gowns has elastic on it but not secured and the other gown has no elastic at the left wrist at all. ======================manufacturer response for isolation gown, kimberly clark isolation gown (per site reporter). ======================e-mail to company rep, no response yet. What was the original intended procedure? Protect staff from exposure to infectious agents from a patient in an isolation room. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3062647 |
| MDR Report Key | 3062647 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-04-10 |
| Report Date | 2013-04-11 |
| Date Reported to FDA | 2013-04-11 |
| Date Reported to Mfgr | 2013-04-17 |
| Date Added to Maude | 2013-04-17 |
| 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 | * |
| Generic Name | GOWN, ISOLATION |
| Product Code | FYC |
| Date Received | 2013-04-11 |
| Model Number | KC200 |
| Catalog Number | 69979-87 |
| Lot Number | LG 3 041 |
| 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 | 2013-04-11 |