MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-28 for COMANECI PETIT ANPP3188 manufactured by Rapid-medical Ltd..
[177378645]
Manufacturer narrative: according to the physician the device was operated as expected, attempts were made to obtain specific procedure information, however no further details were provided data: this report was late due to the webtrade enrollment process, the company purchased digital certificate from comsign as recommended at https://www. Fda. Gov/industry/about-esg/esg-appendix-c-digital-certificates), the comsign certificate that the company bought was approved for the registration of rapid medical webtrader account, however, once the company tried to submit the demo mdr, it was found out that comsign service cannot provide. P12 private key as required. Therefore, the company needed to contact anther digital certificate supplier (out of (b)(4)) that is able to provide the required certificate.
Patient Sequence No: 1, Text Type: N, H10
[177378646]
Rapid-medical received information regarding comaneci petit device being left inside the patient. No specific details were given regarding the cause of the event or the attempts to retrieve the device. The physician claimed it is not due to a malfunction of the device and decided to leave device within the patient, the patient did not worsen as a result of this event, no further surgical intervention is planned, the patient is on anti-platelets therapy. Attempts were made to obtain specific procedure and device information; however, the attempts were unsuccessful. This case was performed out of us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009957947-2020-00001 |
| MDR Report Key | 9636167 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2020-01-28 |
| 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 ORIT YANIV |
| Manufacturer Street | CARMEL BUILDING, POB 337 |
| Manufacturer City | YOKNEAM, ISRAEL 2069205 |
| Manufacturer Country | IS |
| Manufacturer Postal | 2069205 |
| Manufacturer G1 | RAPID MEDICAL LTD |
| Manufacturer Street | CARMEL BUILDING, POB 337 |
| Manufacturer City | 2069205 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMANECI PETIT |
| Generic Name | COMANECI PETIT |
| Product Code | PUU |
| Date Received | 2020-01-28 |
| Catalog Number | ANPP3188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAPID-MEDICAL LTD. |
| Manufacturer Address | CARMEL BUILDING POB 337 YOKNEAM, 2069205 IS 2069205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-01-28 |