MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-10-16 for TENSOR CP981 FOR MAMMARY MOLE manufactured by Integra Microfrance S.a.s..
[90547825]
Integra has completed their internal investigation. Results: evaluation of returned device; the tensor is very hard to use when assembled on 4th position. The axle is distorted and not compliant to our manufacturing specifications. There are numerous impacts on biggest part of tensor , around the 4 drillings. Dhr review; no anomalies that could be associated with the complaint were observed. Complaints history; no adverse trend - first occurrence of this risk for this device. Conclusion: the most probable cause of this distortion is an excessive constraint on the device during use or assembling.
Patient Sequence No: 1, Text Type: N, H10
[90547826]
It was reported that the mammary tensor do not tight enough. Medical staff have to call another op on another floor to have another one. Surgery was delayed 45 minutes and haemostasis was difficult as the tensile on the breath was not enough. No patient injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00118 |
| MDR Report Key | 6952468 |
| Report Source | FOREIGN |
| Date Received | 2017-10-16 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2017-06-30 |
| Date Added to Maude | 2017-10-16 |
| 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 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 | 2017-10-16 |
| Returned To Mfg | 2017-09-28 |
| Catalog Number | CP981 |
| Lot Number | 2212037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-16 |