MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for CODMAN / J&J MEDICAL CO. UNK CH2052 manufactured by J&j Medical.
[68285]
In an attempt to remove a portion of bone from capsular tissue at the proximal interphalangeal joint utilizing scissors which "crush" tissue, rather than cut. The bone fractured down the shaft of the proximal phalanx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 109790 |
| MDR Report Key | 109790 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-04-25 |
| Date of Event | 1997-04-11 |
| Date Facility Aware | 1997-04-11 |
| Report Date | 1997-04-25 |
| Date Added to Maude | 1997-08-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN / J&J MEDICAL CO. |
| Generic Name | SCISSORS |
| Product Code | HRR |
| Date Received | 1997-07-03 |
| Model Number | UNK |
| Catalog Number | CH2052 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 107887 |
| Manufacturer | J&J MEDICAL |
| Manufacturer Address | 2500 ARBROOK ARLINGTON TX 76014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-03 |