MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2002-01-29 for ST. AMNIOTIC PERFORATOR WHITE DYNJ04230 manufactured by Deroyal Industries, Inc..
[243191]
Dr. Complains that the hook is too sharp and is scratching the patient's head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2001-00050 |
| MDR Report Key | 375350 |
| Report Source | 00,08 |
| Date Received | 2002-01-29 |
| Date of Report | 2001-12-24 |
| Date of Event | 2001-12-18 |
| Date Facility Aware | 2001-12-18 |
| Report Date | 2001-12-18 |
| Date Reported to FDA | 2002-01-23 |
| Date Mfgr Received | 2001-12-24 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2002-02-07 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST. AMNIOTIC PERFORATOR WHITE |
| Generic Name | AMNIOTIC PERFORATOR |
| Product Code | HGE |
| Date Received | 2002-01-29 |
| Returned To Mfg | 2001-12-24 |
| Model Number | NA |
| Catalog Number | DYNJ04230 |
| Lot Number | 231771/1B1378 |
| 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 | 364463 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | ST AMNIOTIC PERFORATOR WHITE |
| Baseline Generic Name | AMNIOTIC PERFORATOR |
| Baseline Model No | NA |
| Baseline Catalog No | DYNJ04230 |
| Baseline ID | NA |
| Baseline Device Family | ST AMNIOTIC PERFORATOR WHITE |
| 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 | 2002-01-29 |