MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-21 for TRAY,PREP,EXIDINE-4 PREOP 4489 manufactured by Carefusion.
[1773769]
Dr. Called to report that earlier today a patient of his "developed a chemical burn in the vaginal area" after being prepped with chg. (chlorhexidine gluconate)
Patient Sequence No: 1, Text Type: D, B5
[8745820]
A sample or a lot number were not provided for evaluation; therefore a thorough investigation into the reported issue could not be performed. However, inspection receiving results of the solution received in the last year was reviewed and no anomalies were found, solution was in compliance with all the quality requirements. Warnings in the label copy of the chg solution indicates the following: do not use: if you are allergic to chlorhexidine gluconate or any other ingredients do not use in contact with meninges or in genital area or as a preoperative skin preparation of the head or face.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2010-00011 |
| MDR Report Key | 1878055 |
| Report Source | 05 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-09-24 |
| Date Mfgr Received | 2010-09-24 |
| Date Added to Maude | 2010-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAY,PREP,EXIDINE-4 PREOP |
| Generic Name | TRAY,PREP,EXIDINE-4 PREOP |
| Product Code | OJU |
| Date Received | 2010-10-21 |
| Model Number | 4489 |
| Catalog Number | 4489 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-21 |