MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for GOMCO 02-02-0501 manufactured by Allied Healthcare Products, Inc..
[104445015]
Patient Sequence No: 1, Text Type: N, H10
[104445016]
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.
Patient Sequence No: 1, Text Type: D, B5
[105951909]
Patient Sequence No: 1, Text Type: N, H10
[105951910]
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.
Patient Sequence No: 1, Text Type: D, B5
[105952314]
For type of device: clamp, circumcision.
Patient Sequence No: 1, Text Type: N, H10
[105952315]
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.
Patient Sequence No: 1, Text Type: D, B5
[105952451]
Patient Sequence No: 1, Text Type: N, H10
[105952452]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7398713 |
| MDR Report Key | 7398713 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-09 |
| Report Date | 2018-03-21 |
| Date Reported to FDA | 2018-03-21 |
| Date Reported to Mfgr | 2018-03-21 |
| Date Added to Maude | 2018-04-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | GOMCO |
| Generic Name | CLAMP, CIRCUMCISION |
| Product Code | HFX |
| Date Received | 2018-04-05 |
| Model Number | 02-02-0501 |
| Catalog Number | 02-02-0501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. SAINT LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-05 |