MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN manufactured by Integra Microfrance S.a.s..
[46468084]
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
[46468085]
Patient 3: it was reported that during an ear procedure in the doctor's office, the device was hard to use, the resistance of the clamp resulted in an increase of the manual pressure of the operator therefore there was a movement each time unpredictable and aggressive to the surrounding anatomical environment, which result in superficial injury of the external auditory canals and eardrums without perforation, causing pain. The patient was treated with antibiotics ear drops, steroids and pain medication. Patient is expected to recover.
Patient Sequence No: 1, Text Type: D, B5
[47427683]
Integra has completed their internal investigation on june 7, 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; the handles are harder to work than it usually is. However, they are still compliant with the manufacturing specifications and work properly after lubrication. Dhr review; no nonconformity for this lot. Complaints history; no complaint for this lot. Conclusion: the most probable cause of this stiffness is the lack of regular lubrication during the reprocessing of the forceps.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00085 |
| MDR Report Key | 5696088 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-04-25 |
| Date Mfgr Received | 2016-06-07 |
| Device Manufacturer Date | 2015-12-29 |
| Date Added to Maude | 2016-06-02 |
| 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 | DENTAL HYGIENIST |
| 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 | FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN |
| Generic Name | PFM11 |
| Product Code | KAE |
| Date Received | 2016-06-02 |
| Returned To Mfg | 2016-04-28 |
| Catalog Number | MCO13A |
| Lot Number | 144211 |
| 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 | 2016-06-02 |