MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for KNIFE MCO5D MICROFRANCE SUCTION RND 2MM manufactured by Integra Microfrance S.a.s..
[133351638]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133351639]
A doctor reported that on (b)(6) 2018 while adjusting the shaft of the mco5d knife microfrance suction rnd, during first time use, there was a fracture in the connection between two parts. A (b)(6) male patient was prepped for an unspecified surgery. There was no patient contact, patient injury/death alleged. There was approximately 0. 5 hour (30 minutes) of delay in surgery. Additional information received on 28dec2018 stated that the surgical delay did not cause an impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00003 |
| MDR Report Key | 8252842 |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2019-01-16 |
| 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 | USER 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 | KNIFE MCO5D MICROFRANCE SUCTION RND 2MM |
| Generic Name | PFM11 |
| Product Code | JYO |
| Date Received | 2019-01-16 |
| Catalog Number | MCO5D |
| Lot Number | 2789466 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-16 |