MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-26 for SMARTTOUCH SMARTTOUCH CPR3H manufactured by Manufactured For Microport Crm S.r.l..
| Report Number | 1000165971-2019-00501 |
| MDR Report Key | 8930305 |
| Date Received | 2019-08-26 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-08-07 |
| Date Facility Aware | 2019-08-07 |
| Date Mfgr Received | 2019-10-18 |
| Date Added to Maude | 2019-08-26 |
| 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 | LAURA OUAKI |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Manufacturer Phone | 0146013429 |
| Manufacturer G1 | EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTTOUCH |
| Generic Name | PROGRAMMER, PACEMAKER |
| Product Code | OSR |
| Date Received | 2019-08-26 |
| Returned To Mfg | 2019-08-22 |
| Model Number | SMARTTOUCH CPR3H |
| Catalog Number | SMARTTOUCH CPR3H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURED FOR MICROPORT CRM S.R.L. |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR CLAMART, 92140 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-26 |