MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for MAYO CLAMP UNK manufactured by Medline Industries, Inc..
[121461570]
During a vaginal delivery, the single use mayo clamp broke and injured the finger of the ob physician (per report did not require any further medical care). This event did not involve the patient. Reporting for awareness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901330 |
| MDR Report Key | 7901330 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-08-29 |
| Report Date | 2018-09-20 |
| Date Reported to FDA | 2018-09-20 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | MAYO CLAMP |
| Generic Name | RETRACTOR, VAGINAL |
| Product Code | HDL |
| Date Received | 2018-09-24 |
| Model Number | UNK |
| Lot Number | UNK |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |