MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for MEDLINE INDUSTRIES, INC. DYNDF1117 manufactured by Medline Industries, Inc..
[111195705]
Patient Sequence No: 1, Text Type: N, H10
[111195706]
The tip of the hemostat in the circumcision kit was extremely sharp and would have pierced the patient's penis had it been used. This has occurred on several occasions and requires the physicians to retrieve another hemostat. Some of the hemostats are more blunt than others.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7605228 |
| MDR Report Key | 7605228 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-06-04 |
| Report Date | 2018-06-05 |
| Date Reported to FDA | 2018-06-05 |
| Date Reported to Mfgr | 2018-06-05 |
| Date Added to Maude | 2018-06-15 |
| 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 |
| 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 | MEDLINE INDUSTRIES, INC. |
| Generic Name | CIRCUMCISION KIT |
| Product Code | HFX |
| Date Received | 2018-06-15 |
| Model Number | DYNDF1117 |
| Catalog Number | DYNDF1117 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-15 |