MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1999-12-28 for HARDY BIVALVE SPECULA 80-1351 manufactured by Johnson & Johnson Professional, Inc..
[162019]
International affiliate that the screw broke when the surgeon removed the specula following the procedure. Extended o. R. Was 1. 5 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1999-00218 |
| MDR Report Key | 256996 |
| Report Source | 01,07 |
| Date Received | 1999-12-28 |
| Date of Report | 1999-12-28 |
| Date Mfgr Received | 1999-12-02 |
| Date Added to Maude | 2000-01-03 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARDY BIVALVE SPECULA |
| Generic Name | SPECULUM, ENT |
| Product Code | EPY |
| Date Received | 1999-12-28 |
| Returned To Mfg | 1999-12-07 |
| Model Number | NA |
| Catalog Number | 80-1351 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 248871 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | HARDY BIVALVE SPECULA |
| Baseline Generic Name | SPECULUM, ENT |
| Baseline Model No | NA |
| Baseline Catalog No | 80-1351 |
| Baseline ID | NA |
| Baseline Device Family | HARDY BIVALVE SPECULA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-28 |