MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-20 for GAC PLASTIC MOUTHGUARD MATERIAL 25-200-34 manufactured by Dentslpy Gac International.
[20514524]
It was reported that, a patient possibly had an allergic reaction to a mouthguard, after several months of use. Outcome of the event is not known after multiple follow-up attempts.
Patient Sequence No: 1, Text Type: D, B5
[20823322]
While it is unknown if the mouthguard involved in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequence being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. The device was not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2310178-2006-00504 |
| MDR Report Key | 771460 |
| Report Source | 05 |
| Date Received | 2006-10-20 |
| Date of Report | 2006-09-22 |
| Date Mfgr Received | 2006-09-22 |
| Date Added to Maude | 2006-10-23 |
| 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 | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | SUSQUEHANA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY RAINTRES ESSIX |
| Manufacturer Street | 4001 DIVISION ST. |
| Manufacturer City | METAIRIE LA 70002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 70002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAC PLASTIC MOUTHGUARD MATERIAL |
| Generic Name | DYJ |
| Product Code | DYJ |
| Date Received | 2006-10-20 |
| Model Number | NA |
| Catalog Number | 25-200-34 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 759244 |
| Manufacturer | DENTSLPY GAC INTERNATIONAL |
| Manufacturer Address | * BOHEMIA NY * US |
| Baseline Brand Name | GAC PLASTIC MOUTHGUARD MATERIAL |
| Baseline Generic Name | DYJ |
| Baseline Model No | NA |
| Baseline Catalog No | 25-200-34 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-20 |