MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1997-12-15 for ULTIMA LEAD APRON 269684 manufactured by E-z-em, Inc..
[74296]
Customer rec'd replacement product from the apron recall and claimed that the replacement had a hole in the lead. E-z-em is filing this event due to the potential for harm had this not been caught by the x-ray technologist.
Patient Sequence No: 1, Text Type: D, B5
[7830215]
E-z-em, inc was unable to determine the exact date of manufacture for the apron due to the inability to obtain the distributor purchase order number. However, the lot represents product manufactured subsequent to june 1997.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-1997-00010 |
| MDR Report Key | 139883 |
| Report Source | 06,08 |
| Date Received | 1997-12-15 |
| Date of Report | 1997-10-20 |
| Date of Event | 1997-10-20 |
| Date Facility Aware | 1997-10-20 |
| Report Date | 1997-10-20 |
| Date Reported to Mfgr | 1997-10-20 |
| Date Mfgr Received | 1997-10-20 |
| Date Added to Maude | 1997-12-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIMA LEAD APRON |
| Generic Name | LEAD PROTECTIVE GARMENT |
| Product Code | EAJ |
| Date Received | 1997-12-15 |
| Model Number | NA |
| Catalog Number | 269684 |
| Lot Number | 97206 |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136569 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 5 NORTH PEARL ST. PORTCHESTER NY 10573 US |
| Baseline Brand Name | ULTIMA LEAD APRON |
| Baseline Generic Name | LEAD PROTECTIVE APRON |
| Baseline Model No | NA |
| Baseline Catalog No | 269684 |
| Baseline ID | NA |
| Baseline Device Family | ULTIMA LEAD PROTECTIVE PRODUCT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790080 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-15 |