MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-24 for COMBO-TIP EVACUATOR ZET manufactured by Crosstex International Inc..
[124956945]
The facility reported that while using a crosstex combo-tip evacuator, shards of plastic protruding from the tip caused the patient to bleed. The customer did not return the product for crosstex quality investigation. Limited information related to this complaint and the extent of the reported injuries was provided. The product was replaced with another combo-tip evacuator. Crosstex has not received any complaints similar to this event. This complaint will continue to be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[124956946]
The facility reported that while using a crosstex combo-tip evacuator, shards of plastic protruding from the tip caused the patient to bleed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006008984-2018-00001 |
| MDR Report Key | 8003381 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-04 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2018-10-24 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SADIE MARTIN |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL |
| Manufacturer Street | 534 VINE AVENUE |
| Manufacturer City | SHARON PA 16146 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 16146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBO-TIP EVACUATOR |
| Generic Name | ORAL CAVITY EVACUATOR |
| Product Code | EHZ |
| Date Received | 2018-10-24 |
| Model Number | ZET |
| Lot Number | 08/31/171, 08/18/171, 04/19/17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Address | 534 VINE AVENUE SHARON PA 16146 US 16146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-24 |