MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-22 for SCHEIN COVER FILM 100-9869 manufactured by Metrex Research.
[20859361]
A dental office reported that a patient had alleged experiencing a reaction with symptoms of a rash, swelling, and severe pain after having come in contact with surfaces in the office which had been covered with a sheet of schein cover film or cleaned with caviwipes and cavicide.
Patient Sequence No: 1, Text Type: D, B5
[21140819]
Specific information with regard to the patient's gender, age, and weight were not provided. No lot number or expiration date was provided. It was reported that the patient had sought medical attention at the emergency room on two (2) separate occasions. The patient had returned to the office on (b)(6) 2013 and alleged that a second reaction had occurred. The patient was prescribed antibiotics for treatment. The patient has not contacted the office with any further information; therefore, the root cause of the reaction and the patient's health status remains unknown. Metrex has requested that the complainant report any new information received with regard to this patient. An update will be provided if any new information becomes available. The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722021-2013-00029 |
| MDR Report Key | 3484009 |
| Report Source | 05 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-10-29 |
| Date Mfgr Received | 2013-10-29 |
| Date Added to Maude | 2013-11-22 |
| 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 ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | METREX RESEARCH |
| Manufacturer Street | 28210 WICK ROAD |
| Manufacturer City | ROMULUS MI 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHEIN COVER FILM |
| Generic Name | COVER, BARRIER, PROTECTIVE |
| Product Code | MMP |
| Date Received | 2013-11-22 |
| Catalog Number | 100-9869 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METREX RESEARCH |
| Manufacturer Address | 28210 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-11-22 |