MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-31 for HEANY CLAMP GL 3100 * manufactured by Allegiance Healthcare Corp..
[117540]
End of heany clamp broke off during use. Pt was undergoing abdominal hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015335 |
| MDR Report Key | 204580 |
| Date Received | 1998-12-31 |
| Date of Report | 1998-12-30 |
| Date of Event | 1998-12-17 |
| Date Added to Maude | 1999-01-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HEANY CLAMP |
| Generic Name | SURGICAL CLAMP |
| Product Code | HCZ |
| Date Received | 1998-12-31 |
| Returned To Mfg | 1998-12-29 |
| Model Number | GL 3100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 198703 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUGEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | HEANEY HYSTERECTOMY FORCEPS |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | GL3100 |
| Baseline Catalog No | GL3100 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-31 |