MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for ARGYLE 8881450004 manufactured by Mitg - Kenmex.
[93197877]
Submit date: 11/22/2017. An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93197878]
The customer reports that the cap came off and it go into patient throat and was removed with no complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2017-05245 |
| MDR Report Key | 7053435 |
| Date Received | 2017-11-22 |
| Date of Report | 2018-03-21 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-13 |
| Date Added to Maude | 2017-11-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | MITG - KENMEX |
| Manufacturer Street | CALLE 9 SUR NO. 1113 CUIDAD |
| Manufacturer City | TIJUANA,NA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARGYLE |
| Generic Name | MOUTHPIECE, SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2017-11-22 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |