MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for JUSTRIGHT 5MM STAPLER JR-ST25-2.0-6 manufactured by Bolder Surgical.
| Report Number | 3010377594-2020-00001 |
| MDR Report Key | 9908220 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBORAH PACHECO |
| Manufacturer Street | 331 S. 104TH ST. SUITE 200 |
| Manufacturer City | LOUISVILLE, CO |
| Manufacturer Country | US |
| Manufacturer Phone | 2877134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUSTRIGHT 5MM STAPLER |
| Generic Name | MANUAL SURGICAL INSTRUCMENT FOR GENERAL USE |
| Product Code | GAG |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Model Number | JR-ST25-2.0-6 |
| Catalog Number | JR-ST25-2.0-6 |
| Lot Number | 75HI1221 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOLDER SURGICAL |
| Manufacturer Address | 331 S. 104TH ST. SUITE 200 LOUISVILLE, CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |