MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2008-12-11 for IMPERV. ISOLATION GOWN W/THUMBHOOKS 30/C 42110PG manufactured by Cardinal Health.
[19463431]
Nurse developed sinus issues upon wearing gown. She saw a physician and was treated with antibiotics for a sinus infection.
Patient Sequence No: 1, Text Type: D, B5
[19715224]
Additional lot #: 08jaw250. Additional device manufacture date: 9/2008. Complaint and sample forwarded to plant for investigation. Follow up report will be filed once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2008-00101 |
| MDR Report Key | 1285949 |
| Report Source | 04,07 |
| Date Received | 2008-12-11 |
| Date of Report | 2008-12-11 |
| Date of Event | 2008-11-04 |
| Date Mfgr Received | 2008-12-02 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2009-11-16 |
| 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 RD. BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPERV. ISOLATION GOWN W/THUMBHOOKS 30/C |
| Generic Name | GOWN, ISOLATION, SURGICAL |
| Product Code | FYC |
| Date Received | 2008-12-11 |
| Catalog Number | 42110PG |
| Lot Number | 08HAW217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-11 |