MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-07-07 for SHARPOINT AC-0586D manufactured by Surgical Specialties Mexico.
| Report Number | 3010692967-2019-00020 |
| MDR Report Key | 8766154 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-07-07 |
| Date of Report | 2019-07-07 |
| Date of Event | 2019-06-09 |
| Date Facility Aware | 2019-06-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2019-06-09 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2018-11-06 |
| Date Added to Maude | 2019-07-07 |
| 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 |
| Manufacturer G1 | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Street | CORREDOR TIJUANA-ROSARITO 2000 #24702B EJIDO FRANCISCO VILLA |
| Manufacturer City | TIJUANA 22235 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPOINT |
| Product Code | GAB |
| Date Received | 2019-07-07 |
| Model Number | AC-0586D |
| Catalog Number | AC-0586D |
| Lot Number | AADH229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES MEXICO |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 EJIDO FRANCISCO VILLA TIJUANA 22235 MX 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-07 |