MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for DURAPLUG 0078 manufactured by Surgical Specialties Corporation Mexico.
| Report Number | 3010692967-2020-00009 |
| MDR Report Key | 9695289 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-15 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2020-01-21 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2020-02-11 |
| 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 | MS. KELLY KNAPPENBERGER |
| Manufacturer Street | 1100 BERKSHIRE BLVD. STE 308 |
| Manufacturer City | READING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal | 19608 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAPLUG |
| Generic Name | EXTENDED WEAR PUNCTUM PLUG |
| Product Code | LZU |
| Date Received | 2020-02-11 |
| Model Number | 0078 |
| Catalog Number | 0078 |
| Lot Number | AADN965 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION MEXICO |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 #24702 B EJIDO FRANCISCO VILLA TIJUANA 22235 MX 22235 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-02-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |