MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-04 for * OB-1000 manufactured by Cardinal Health 200, Llc.
[2770787]
During a circumcision procedure md was cutting the foreskin of the baby's penis and in the process nicked the head of the penis. The nick (cut) was tiny and there was only minimal bleeding which was stopped with manual pressure. Upon inspection of the scissors that came with the circumcision kit from carefusion, cardinal health the md and staff involved in the procedure noticed that the blunt tip of one of the scissors blades was not blunt but it had a sharp edge which caused the nick. The scissors included in the kit was supposed to be sharp/blunt scissors. Bleeding which was minimal stopped after md applied manual pressure. No stitches were used. Family was notified by md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2653971 |
| MDR Report Key | 2653971 |
| Date Received | 2012-07-04 |
| Date of Report | 2012-06-28 |
| Date of Event | 2012-06-22 |
| Report Date | 2012-06-28 |
| Date Reported to FDA | 2012-07-04 |
| Date Added to Maude | 2012-07-12 |
| 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, DISPOSABLE |
| Product Code | OHG |
| Date Received | 2012-07-04 |
| Returned To Mfg | 2012-07-03 |
| Model Number | OB-1000 |
| Catalog Number | OB-1000 |
| Lot Number | 0000434743 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1430 WAUKEGAN ROAD MPKB-2B WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-04 |