MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for UTERINE CLAMP ANG 300MM MB184R manufactured by Contract Manufacturer: Tontarra Medizintechnick.
[51356814]
Manufacturing site evaluation: on-going.
Patient Sequence No: 1, Text Type: N, H10
[51356815]
It has been reported that the jaw of a uterine clamp broke. It has been reported that there was unknown surgical delay and unknown intervention.
Patient Sequence No: 1, Text Type: D, B5
[71636761]
Investigation of the returned device indicated breakage at the area of the box hole; where the device is at its thinnest. All specifications (material and measurements) were valid at the time of production, no additional complaints have been received related to this item number. No material or manufacturing defects found. The breakage of the device is likely related to overloading or incorrect handling during use/processing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2016-00641 |
| MDR Report Key | 5828140 |
| Date Received | 2016-07-27 |
| Date of Report | 2017-03-30 |
| Date Facility Aware | 2016-06-28 |
| Date Mfgr Received | 2016-06-28 |
| Date Added to Maude | 2016-07-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK |
| Manufacturer Street | 15 DAIMLERSTR. |
| Manufacturer City | WURMLINGEN 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UTERINE CLAMP ANG 300MM |
| Generic Name | CLAMP |
| Product Code | HGC |
| Date Received | 2016-07-27 |
| Model Number | MB184R |
| Catalog Number | MB184R |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: TONTARRA MEDIZINTECHNICK |
| Manufacturer Address | 15 DAIMLERSTR. WURMLINGEN 78573 GM 78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-27 |