MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for INTEGRA? JARIT? 505-320 manufactured by Integra York Pa, Inc..
[123371737]
Heaney-ballentine hyst forcep broke while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7955453 |
| MDR Report Key | 7955453 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-09-21 |
| Report Date | 2018-10-09 |
| Date Reported to FDA | 2018-10-09 |
| Date Reported to Mfgr | 2018-10-11 |
| Date Added to Maude | 2018-10-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA? JARIT? |
| Generic Name | FORCEPS, SURGICAL, GYNECOLOGICAL |
| Product Code | HCZ |
| Date Received | 2018-10-11 |
| Model Number | 505-320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |