MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for FORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH manufactured by Integra Microfrance S.a.s..
[107588187]
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
[107588188]
A field sales manager reported on behalf of the customer that on (b)(6) 2017, the tip of the mcen116 forceps mcen116 dia 4. 0mm vaughan punch was broken. The product was placed in position at sphenoid face and a bite was attempted on the medical sphenoid face. The bone was fairly thin but the tip broke instantly and fell into the sphenoid sinus. However, no patient injury, no medical revision or intervention was done and no delay in surgery was reported. Additional information has been requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[132629777]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed. The serial/lot number was not provided therefore a dhr review and investigation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2018-00068 |
| MDR Report Key | 7487823 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-05-04 |
| 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 | FORCEPS MCEN116 DIA 4.0MM VAUGHAN PUNCH |
| Generic Name | PFM11 |
| Product Code | KAY |
| Date Received | 2018-05-04 |
| Catalog Number | MCEN116 |
| 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 | 2018-05-04 |