MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for HEANEY-BALLENTINE HYST FCP CVD 505320 manufactured by Integra York, Pa Inc..
[128284835]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[128284836]
It was reported that on (b)(6) 2018, a (b)(6) patient was prepped for a total abdominal hysterectomy and bilateral salpingo-oophorectomy procedure. The 505320 heaney-ballentine hyst fcp cvd broke while in use during the procedure. There was patient contact, but it is unknown if there was any injury or a surgical delay. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00136 |
| MDR Report Key | 8056644 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEANEY-BALLENTINE HYST FCP CVD |
| Generic Name | N/A |
| Product Code | HCZ |
| Date Received | 2018-11-09 |
| Catalog Number | 505320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |