MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-10-03 for * 22181 manufactured by Coopersurgical, Inc..
[450455]
Physician and assistant report they used this device before, but this time it seemed to malfunction. They said the needle came off and stabbed the physician in the thigh. Central supply was unable to provide any more information on the device. Reference medwatch 3400280000-2005-8012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2005-00027 |
| MDR Report Key | 698988 |
| Report Source | 06 |
| Date Received | 2005-10-03 |
| Date of Report | 2005-09-30 |
| Date Mfgr Received | 2005-09-19 |
| Date Added to Maude | 2006-04-14 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CARTRIDGE SYRINGE |
| Product Code | EJI |
| Date Received | 2005-10-03 |
| Model Number | 22181 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688074 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US |
| Baseline Brand Name | * |
| Baseline Generic Name | CARTRIDGE SYRINGE |
| Baseline Model No | 22181 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2005-10-03 |