MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-07 for HARRIS UTERINE INJECTOR (HUI) 6002 NA manufactured by Coopersurgical, Inc..
[233109]
The distal tip of a harris uterine injector (hui)-a single 1" to 3" piece-broke off during a procedure. The broken piece was immediately manually retrieved (forceps). There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2001-00026 |
| MDR Report Key | 351149 |
| Report Source | 05 |
| Date Received | 2001-09-07 |
| Date of Report | 2001-09-05 |
| Date of Event | 1999-01-01 |
| Date Mfgr Received | 1999-03-11 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 2001-09-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS, DIR. |
| Manufacturer Street | 15 FOREST PARKWAY |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2039296321 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARRIS UTERINE INJECTOR (HUI) |
| Generic Name | UTERINE INJECTOR |
| Product Code | HQA |
| Date Received | 2001-09-07 |
| Returned To Mfg | 1999-03-15 |
| Model Number | 6002 |
| Catalog Number | NA |
| Lot Number | 712071 |
| ID Number | NA |
| Device Expiration Date | 2000-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 340435 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 15 FOREST PKWY. SHELTON CT 06484 US |
| Baseline Brand Name | HARRIS UTERINE INJECTOR (HUI) |
| Baseline Generic Name | UTERINE INJECTOR |
| Baseline Model No | 6002 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2001-09-07 |