MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-20 for NEEDLE HOLDER manufactured by Integra-jarit Instruments.
[48029758]
A piece of the needle holder broke off while doing a posterior enterocele repair. Both pieces thought to be recovered. Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number below.
Patient Sequence No: 1, Text Type: D, B5
[54925816]
Add'l info received from reporter on 07/28/2016 on report # mw5062959. (mfr info edited).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062959 |
| MDR Report Key | 5741397 |
| Date Received | 2016-06-20 |
| Date of Report | 2016-07-16 |
| Date of Event | 2016-04-15 |
| Date Added to Maude | 2016-06-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | NEEDLE HOLDER |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2016-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA-JARIT INSTRUMENTS |
| Manufacturer Address | 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-20 |