MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-14 for TENSOR CP981 FOR MAMMARY MOLE manufactured by Integra Microfrance S.a.s..
[67383857]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[67383858]
It was reported that during a right breast reduction surgery, the support of the screw broke due to detachment of the axis causing an abrasion. No consequences reported as the injured skin was removed during the breast reduction.
Patient Sequence No: 1, Text Type: D, B5
[69409069]
Integra has completed their internal investigation on february 23, 2017. The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history. Results: evaluation of returned device; the "t" component for hinge between two arms of the tensor is unwelded from the main arm. A thorough observation of the welding area shows appropriate chamfer and no defect on the welding. Dhr review; no anomalies that could be associated with the complaint were observed. Complaints history; first occurrence of this risk for this device - no adverse trend. Conclusion: the cause cannot be determined with absolute certainty. The origin of the welding breakage can be due to an excessive effort on the "t" part during assembling or disassembling of the tensor handle or to an undetected welding defect. However this tensor was manufactured in may 2011 and no maintenance was performed by the integra service and repair. The tensor's ifu nt078 recommends to "ensure proper functioning of dismantable devices and devices with accessories, check the assembly and the functionality of all elements of the device before use. " the age of the instrument, the lack of maintenance and the recommendations of the ifu reasonably conclude that this event is not attributable to integra.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2017-00018 |
| MDR Report Key | 6329612 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-14 |
| Date of Report | 2017-01-23 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2017-02-14 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| 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 | 3 |
| Brand Name | TENSOR CP981 FOR MAMMARY MOLE |
| Generic Name | PFM11 |
| Product Code | FTY |
| Date Received | 2017-02-14 |
| Returned To Mfg | 2017-02-01 |
| Catalog Number | CP981 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2017-02-14 |