MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-15 for SCRUB BRUSH-SPONGE, SURGICAL 4457A manufactured by Carefusion.
[1299161]
Red bumps on healthcare worker's hands.
Patient Sequence No: 1, Text Type: D, B5
[8536237]
Since samples were not made available and no lot number was provided, a thorough investigation could not be completed. For each received lot of solution that is used to manufacture the surgical scrub brush sponge, catalog no 4457a, a review of the certificate of analysis and an identification test is performed. Additional finished goods testing are completed on a skip lot basis, which includes a skin irritation study, chemical and microbiological analysis. Review of these test records does not indicate failure of previous lots. Carefusion will continue to monitor and trend this issue and utilize the information as part of our continuous improvement program.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2010-00010 |
| MDR Report Key | 1669100 |
| Report Source | 05,06 |
| Date Received | 2010-04-15 |
| Date of Report | 2010-04-15 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-16 |
| Date Added to Maude | 2012-03-01 |
| 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 | 0 |
| 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 City | MEXICALI |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB BRUSH-SPONGE, SURGICAL |
| Generic Name | SURGICAL SCRUB BRUSH |
| Product Code | GEC |
| Date Received | 2010-04-15 |
| Model Number | 4457A |
| Catalog Number | 4457A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2010-04-15 |