MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-07 for UTERINE CLAMP ANG 240MM MB355R manufactured by Tontarra Medizintachnik Gmbh.
[129743788]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[129743789]
It was reported that a piece of a uterine clamp broke off during surgery. The issue occurred during use in a hysterectomy procedure. Both parts were recovered; retrieval was confirmed via x-ray. There was a delay of less than 5 minutes during the surgery. There was no known harm to the patient and no further intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00042 |
| MDR Report Key | 8143510 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-02 |
| Date Facility Aware | 2018-11-21 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TONTARRA |
| 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 240MM |
| Generic Name | GYNAECOLOGY AND OBSTETRICS |
| Product Code | GDJ |
| Date Received | 2018-12-07 |
| Model Number | MB355R |
| Catalog Number | MB355R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TONTARRA MEDIZINTACHNIK GMBH |
| Manufacturer Address | 15 DAIMLERSTR. WURMLINGEN, BADEN-WURTTEMBERG 78573 GM 78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-07 |