MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for UNI-PUNCH 9033508 manufactured by Premier Dental Products Co. Dba Premier Medical.
| Report Number | 0002521453-2020-00001 |
| MDR Report Key | 9673222 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2020-02-05 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SANDY ALVES |
| Manufacturer Street | 1710 ROMANO DRIVE |
| Manufacturer City | PLYMOUTH MEETING 19462 |
| Manufacturer Country | US |
| Manufacturer Postal | 19462 |
| Manufacturer Phone | 6102396000 |
| Manufacturer G1 | PREMIER DENTAL PRODUCTS CO. DBA PREMIER MEDICA |
| Manufacturer Street | 1710 ROMANO DRIVE |
| Manufacturer City | PLYMOUTH MEETING 19462 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19462 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-PUNCH |
| Generic Name | BIOPSY PUNCH |
| Product Code | LRY |
| Date Received | 2020-02-05 |
| Catalog Number | 9033508 |
| Lot Number | P17030680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PREMIER DENTAL PRODUCTS CO. DBA PREMIER MEDICAL |
| Manufacturer Address | 1710 ROMANO DRIVE PLYMOUTH MEETING 19462 US 19462 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |