MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for AAMI 4 SMARTSLEEVE SURG GOWN LG 9011 manufactured by Cardinal Health Singapore 225 Pte. Ltd..
| Report Number | 1423537-2020-00443 |
| MDR Report Key | 9881242 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-27 |
| Date of Event | 1980-01-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH SINGAPORE 225 PTE. LTD. |
| Manufacturer Street | 10 KALLANG AVENUE #10-10/18 APERIAN |
| Manufacturer City | EL PASO TX 339510 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 339510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AAMI 4 SMARTSLEEVE SURG GOWN LG |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2020-03-25 |
| Model Number | 9011 |
| Catalog Number | 9011 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH SINGAPORE 225 PTE. LTD. |
| Manufacturer Address | 10 KALLANG AVENUE #10-10/18 APERIAN TX 339510 SN 339510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |