MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-25 for * DYNDF1044 manufactured by Medline Industries, Inc..
[915363]
Prior to performing a circumcision on an infant, the physician assembled the device to check for tightness. The bell was loose after the screw was tightened to its fullest. Additionally, the "jaws" of the hemostat did not oppose tightly when in the locked position with a visible gap noted at the tip of the hemostat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1101543 |
| MDR Report Key | 1101543 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-25 |
| Date of Event | 2008-07-18 |
| Report Date | 2008-07-25 |
| Date Reported to FDA | 2008-07-25 |
| Date Added to Maude | 2008-08-11 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | TRAY, CIRCUMCISION |
| Product Code | OHG |
| Date Received | 2008-07-25 |
| Model Number | DYNDF1044 |
| Catalog Number | * |
| Lot Number | 08DB2039 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1078777 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 NORTHPOINT BLVD. WAUKEGAN IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-25 |