MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-06-30 for EXETER CUP INTRODUCER 28 MM 0927-3-028 manufactured by Howmedica Inc..
[64987]
The screw of the cup introducer would not the handle. This event did not occur during a surgical procedure; therefore, there was no adverse consequence for any pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57386-1997-00018 |
| MDR Report Key | 102735 |
| Report Source | 01,07 |
| Date Received | 1997-06-30 |
| Date of Report | 1997-06-27 |
| Report Date | 1997-06-28 |
| Date Mfgr Received | 1997-05-28 |
| Date Added to Maude | 1997-07-08 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXETER CUP INTRODUCER 28 MM |
| Generic Name | INSTRUMENT |
| Product Code | HXO |
| Date Received | 1997-06-30 |
| Model Number | NA |
| Catalog Number | 0927-3-028 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 101102 |
| Manufacturer | HOWMEDICA INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 07070 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-30 |