N
Patient 1
MAUDE MDR 7398713
- MDR report key
- 7398713
- Report number
- 7398713
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-09
- Date received
- 2018-04-05
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GOMCO | CLAMP, CIRCUMCISION | ALLIED HEALTHCARE PRODUCTS, INC. | HFX | 02-02-0501 | 02-02-0501 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-05 | 0 | 1. O |
Event Narratives#
D
Patient 1
A NEONATE UNDERWENT CIRCUMCISION BY A PROVIDER USING A GOMCO CLAMP. THE CLAMP THAT WAS RETRIEVED FROM STERILE PACKAGING HAD A BASE AND A BELL THAT WERE DIFFERENT SIZES. DESPITE BEING DIFFERENT SIZES, THE INSTRUMENT WAS ABLE TO BE ASSEMBLED AS IF THE PIECES MATCHED. IN ADDITION, THE ETCHING ON THE INSTRUMENTS INDICATING THE SIZE IS ON THE UNDERSIDE OF THE EQUIPMENT, IS EXTREMELY SMALL, AND IS THE SAME COLOR AS THE INSTRUMENT (SILVER METAL). THE NEONATE SUSTAINED A SKIN INJURY THAT REQUIRED UROLOGY CONSULT AND REVISION SURGERY.
N
Patient 1
D
Patient 1
A NEONATE UNDERWENT CIRCUMCISION BY A PROVIDER USING A GOMCO CLAMP. THE CLAMP THAT WAS RETRIEVED FROM STERILE PACKAGING HAD A BASE AND A BELL THAT WERE DIFFERENT SIZES. DESPITE BEING DIFFERENT SIZES, THE INSTRUMENT WAS ABLE TO BE ASSEMBLED AS IF THE PIECES MATCHED. IN ADDITION, THE ETCHING ON THE INSTRUMENTS INDICATING THE SIZE IS ON THE UNDERSIDE OF THE EQUIPMENT, IS EXTREMELY SMALL, AND IS THE SAME COLOR AS THE INSTRUMENT (SILVER METAL). THE NEONATE SUSTAINED A SKIN INJURY THAT REQUIRED UROLOGY CONSULT AND REVISION SURGERY.
N
Patient 1
FOR TYPE OF DEVICE: CLAMP, CIRCUMCISION.
D
Patient 1
A NEONATE UNDERWENT CIRCUMCISION BY A PROVIDER USING A GOMCO CLAMP. THE CLAMP THAT WAS RETRIEVED FROM STERILE PACKAGING HAD A BASE AND A BELL THAT WERE DIFFERENT SIZES. DESPITE BEING DIFFERENT SIZES, THE INSTRUMENT WAS ABLE TO BE ASSEMBLED AS IF THE PIECES MATCHED. IN ADDITION, THE ETCHING ON THE INSTRUMENTS INDICATING THE SIZE IS ON THE UNDERSIDE OF THE EQUIPMENT, IS EXTREMELY SMALL, AND IS THE SAME COLOR AS THE INSTRUMENT (SILVER METAL). THE NEONATE SUSTAINED A SKIN INJURY THAT REQUIRED UROLOGY CONSULT AND REVISION SURGERY.
N
Patient 1
D
Patient 1
A NEONATE UNDERWENT CIRCUMCISION BY A PROVIDER USING A GOMCO CLAMP. THE CLAMP THAT WAS RETRIEVED FROM STERILE PACKAGING HAD A BASE AND A BELL THAT WERE DIFFERENT SIZES. DESPITE BEING DIFFERENT SIZES, THE INSTRUMENT WAS ABLE TO BE ASSEMBLED AS IF THE PIECES MATCHED. IN ADDITION, THE ETCHING ON THE INSTRUMENTS INDICATING THE SIZE IS ON THE UNDERSIDE OF THE EQUIPMENT, IS EXTREMELY SMALL, AND IS THE SAME COLOR AS THE INSTRUMENT (SILVER METAL). THE NEONATE SUSTAINED A SKIN INJURY THAT REQUIRED UROLOGY CONSULT AND REVISION SURGERY.