MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-01-16 for MOGEN CIRCUMCISION CLAMP UNKNOWN manufactured by Carefusion, Inc.
[97426652]
(b)(4) on 19dec2017 bd became aware of this complaint. This record is involved with a legal matter and customer is not to be contacted. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[97426653]
Notice received by legal department states: infant child suffered a partial amputation of his penis during circumcision on (b)(6) 2017. To date there is no further identifying information or serial number for the clamp. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00202 |
| MDR Report Key | 7196292 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-01-16 |
| Date of Report | 2018-01-16 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2018-01-16 |
| 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 |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-01-16 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-16 |