MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-11 for CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY CIT5250 manufactured by Tri-state De Mexico, S. De R.l..
[21670664]
Hospital reported that during a circumcision, skin became trapped between the two blades of the 4 1/2" straight strabismus scissors. The doctor was forced to get the skin out and cut the urethra. Surgery was required to repair the urethra.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004519921-2013-00001 |
| MDR Report Key | 3226418 |
| Report Source | 07 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-06-14 |
| Date of Event | 2013-06-01 |
| Date Mfgr Received | 2013-06-14 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-07-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW PRICE, DIRECTOR |
| Manufacturer Street | 100 CENTURION WAY |
| Manufacturer City | WILLIAMSTON MI 48895 |
| Manufacturer Country | US |
| Manufacturer Postal | 48895 |
| Manufacturer Phone | 5175451135 |
| Manufacturer G1 | TRI-STATE DE MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | CALZADO CIUDAD DE MEXICALI NO. 301 |
| Manufacturer City | MEXICALI 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY |
| Generic Name | OHG: CIRCUMCISION TRAY |
| Product Code | OHG |
| Date Received | 2013-07-11 |
| Model Number | CIT5250 |
| Lot Number | 2013030690 |
| Device Expiration Date | 2015-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRI-STATE DE MEXICO, S. DE R.L. |
| Manufacturer Address | MEXICALI 21397 MX 21397 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-11 |