MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-23 for 25GA ENDGRIPPING FORCEPS 65025S-12 manufactured by Bausch + Lomb.
| Report Number | 0001920664-2019-00160 |
| MDR Report Key | 8816810 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-23 |
| Date of Report | 2019-06-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-08-24 |
| Date Added to Maude | 2019-07-23 |
| 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 | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | BAUSCH + LOMB GMBH |
| Manufacturer Street | IM SCHUHMACHERGEWANN 4 |
| Manufacturer City | HEIDELBERG 69123 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 69123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25GA ENDGRIPPING FORCEPS |
| Generic Name | 25GA ENDGRIPPING FORCEPS |
| Product Code | HNR |
| Date Received | 2019-07-23 |
| Returned To Mfg | 2019-07-12 |
| Model Number | 65025S-12 |
| Lot Number | FS18084693 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | IM SCHUHMACHERGEWANN 4 HEIDELBERG 69123 GM 69123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-23 |