MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-05 for ISOLATION GOWN 69979-87 TM KC 200 manufactured by Kimberly-clark.
[3175446]
Nurse went to put on isolation gown prior to entering isolation room. Put left arm through sleeve and discovered that the elastic was not attached to make the cuff tight around the wrist. The right sleeve upon investigation was found sealed at the hand. Gown not used. It was turned in to infection control who then sent it to safety department. No other gowns found unusable at this time. ======================manufacturer response for isolation gown, kimberley-clark isolation gown (per site reporter). ======================talked to company rep via phone on march 1. He said he would have a mailing label sent for the gown to be returned to them for review. Still waiting for this label. Also, this is an issue that we reported in 2012 twice and still have not received an official letter from the company explaining why the gowns are failing so often. What was the original intended procedure? Protect staff from potential exposure: transmission based precautions, patient in isolation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2992088 |
| MDR Report Key | 2992088 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-02-20 |
| Report Date | 2013-03-05 |
| Date Reported to FDA | 2013-03-05 |
| Date Reported to Mfgr | 2013-03-07 |
| Date Added to Maude | 2013-03-07 |
| 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 | ISOLATION GOWN |
| Generic Name | GOWN, ISLOATION, SURGICAL |
| Product Code | FYC |
| Date Received | 2013-03-05 |
| Model Number | 69979-87 |
| Catalog Number | TM KC 200 |
| Lot Number | LG2 253 |
| 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 | 2013-03-05 |