MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-27 for * DYNFD 1044 manufactured by Medline Industries, Inc..
[19050712]
Disposable circumcision kit contained four pieces which were assembled to do the procedure. During the procedure, the round knob was turned to tighten the bell piece. According to the physician performing the procedure, "the bell piece never felt as if it had a tight seal". The clamp was tightened to the maximum and the bell piece remained loose. The loose seal provided inadequate tension, which resulted in heavy bleeding at the site. Suturing and hemostatic agent were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 976510 |
| MDR Report Key | 976510 |
| Date Received | 2007-11-27 |
| Date of Report | 2007-11-26 |
| Date of Event | 2007-10-29 |
| Report Date | 2007-11-26 |
| Date Reported to FDA | 2007-11-27 |
| Date Added to Maude | 2008-01-10 |
| 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 | FHG |
| Date Received | 2007-11-27 |
| Model Number | DYNFD 1044 |
| Catalog Number | * |
| Lot Number | 07EB1724 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 944446 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 NORTHPOINT BLVD. WAUKEGAN IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-27 |