MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-16 for GLOVE SURGICAL PROTEXIS PI MICRO 2D73PM65 manufactured by Cardinal Health (thailand) 222 Limited.
| Report Number | 1423537-2019-00361 |
| MDR Report Key | 9198635 |
| Date Received | 2019-10-16 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2019-09-23 |
| Date Added to Maude | 2019-10-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Street | 7/111 MOO 4 HIGHWAY #331, MABY |
| Manufacturer City | RAYONG 21140 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 21140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLOVE SURGICAL PROTEXIS PI MICRO |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-10-16 |
| Model Number | 2D73PM65 |
| Catalog Number | 2D73PM65 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Address | 7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-16 |