MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-09 for HIBICLENS DO NOT KNOW manufactured by Zeneca Pharmaceuticals.
[344448]
This is an obese pt who underwent cardiac bypass grafting. As part of the preparation, the patient bathed with hibiclens. In the or, pt was prepped with duraprep from the chin to the pubic bone and widely on the torso, and legs were prepped circumferentially. An arterial line was placed, and that area was prepped with betadine. The surgery went well. The following morning, blisters appeared in the skin folds circumferentially around the patient's neck. Additional blisters developed in the skin folds under breasts, under arms and down the sides, between the thighs, and in a couple of spots on the back. The blistering progressed to full thickness wounds. Silvadene was applied and the patient's wounds have healed, although they are hyperpigmented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 555437 |
| MDR Report Key | 555437 |
| Date Received | 2002-12-09 |
| Date of Report | 2002-12-03 |
| Date of Event | 2002-04-15 |
| Report Date | 2002-12-03 |
| Date Reported to FDA | 2002-12-09 |
| Date Added to Maude | 2004-11-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HIBICLENS |
| Generic Name | ANTISEPTIC ANTIMICROBIAL SKIN CLEANSER |
| Product Code | GEC |
| Date Received | 2002-12-09 |
| Model Number | DO NOT KNOW |
| Catalog Number | DO NOT KNOW |
| Lot Number | DO NOT KNOW |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 545082 |
| Manufacturer | ZENECA PHARMACEUTICALS |
| Manufacturer Address | P.O. BOX 15437 WILMINGTON DE 198505437 US |
| Brand Name | DURAPREP |
| Generic Name | ANTIBACTERIAL, ANTIMICROBIAL PATIENT PREPARATION SOLUTION |
| Product Code | GEC |
| Date Received | 2002-12-09 |
| Model Number | DO NOT KNOW |
| Catalog Number | DO NOT KNOW |
| Lot Number | DO NOT KNOW |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 545083 |
| Manufacturer | 3M HEALTHCARE |
| Manufacturer Address | 3M CENTER BLDG. 275-4E-01 ST. PAUL MN 551441000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-09 |