MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-09 for MOGEN CLAMP GL7021 manufactured by V. Mueller / Carefusion 2200, Inc..
[113635192]
Excessive bleeding following circumcision using mogen clamp. Tip of glans amputated during procedure. Infant transferred to nicu to monitor bleeding. Required plastic surgery repair/glans reattachment and foley catheter for one month during healing process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078294 |
| MDR Report Key | 7673383 |
| Date Received | 2018-07-09 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-05-21 |
| Date Added to Maude | 2018-07-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | MOGEN CLAMP |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2018-07-09 |
| Model Number | GL7021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER / CAREFUSION 2200, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-09 |