MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-13 for SMARTSLEEVE, XX-LARGE 9071 manufactured by Cardinal Health 200, Llc.
[5677692]
A scrub technician experienced dermatitis all over his arms when wearing the gown. He has a history of allergies and will be consulting directly with his dermatologist and having patch testing. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13128904]
The customer was not able to provide the lot number. Without a lot number for traceability, it is not possible to review the device history record. No sample was provided, therefore we are unable to investigate and identify a root cause. All products must meet specifications prior to release to market. Materials used in our manufacturing process meet criteria established for raw material specifications. No action will be taken at this time. We will continue to monitor complaints for reports of a similar nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00018 |
| MDR Report Key | 4683965 |
| Report Source | 05,07 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-13 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-04-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1 BUTTERFIELD TRAIL BLVD |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSLEEVE, XX-LARGE |
| Generic Name | GOWN, SURGICAL |
| Product Code | OEA |
| Date Received | 2015-04-13 |
| Catalog Number | 9071 |
| Lot Number | NO LOT GIVEN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1 BUTTERFIELD TRAIL BLVD EL PASO TX 79906 US 79906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-13 |