MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other,user facility report with the FDA on 2018-08-03 for MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN GL7021 manufactured by Carefusion, Inc.
[115966979]
(b)(4). This complaint was opened from the medwatch report and has no contact information so the customer could not be reached for further information. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[115966980]
Medwatch report mw5078294 states: 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. The sample, pictures, and lot number are not available. Also, there is no contact information from this complaint so we have no way of gathering further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00013 |
| MDR Report Key | 7748237 |
| Report Source | CONSUMER,OTHER,USER FACILITY |
| Date Received | 2018-08-03 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-08-03 |
| Catalog Number | GL7021 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-08-03 |