MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-28 for SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS manufactured by Integra Microfrance S.a.s..
| Report Number | 2523190-2019-00087 |
| MDR Report Key | 8744938 |
| Date Received | 2019-06-28 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-06-18 |
| Date Mfgr Received | 2019-06-18 |
| Date Added to Maude | 2019-06-28 |
| 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. KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUCTION TUBE MCLT50 MALLEAB BLUNT TERRIS |
| Generic Name | PFM11 |
| Product Code | KAC |
| Date Received | 2019-06-28 |
| Returned To Mfg | 2019-06-21 |
| Catalog Number | MCLT50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-28 |