MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-03 for CONCISE CEMENT SCULPS KIT manufactured by Smith & Nephew Richards, Inc..
[13099]
Notified mfr 10/3/94 of breakage of a blue cement currette. The broken piece remains missing. No pt injury is known at this time. Radiology films are negative for foreign object. Upon investigation of the box, it was noticed that another currette, still packaged, was broken. Both have the same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005015 |
| MDR Report Key | 19395 |
| Date Received | 1995-02-03 |
| Date of Report | 1995-01-26 |
| Date of Event | 1994-09-20 |
| Date Added to Maude | 1995-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONCISE CEMENT SCULPS KIT |
| Product Code | LZV |
| Date Received | 1995-02-03 |
| Lot Number | ID54640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19309 |
| Manufacturer | SMITH & NEPHEW RICHARDS, INC. |
| Manufacturer Address | MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-02-03 |