MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-12 for REALIZE ENDOSCOPIC DISSECTOR UNK RGBRS1 manufactured by Obtech Medical Sarl_.
[1553910]
The customer reports that the product was received with a hole in the tyvek. It was not used on a patient.
Patient Sequence No: 1, Text Type: D, B5
[8647186]
(b)(4): information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005992282-2010-00128 |
| MDR Report Key | 1681147 |
| Report Source | 06 |
| Date Received | 2010-05-12 |
| Date of Report | 2010-04-19 |
| Date of Event | 2010-04-16 |
| Date Mfgr Received | 2010-07-15 |
| Device Manufacturer Date | 2010-03-16 |
| Date Added to Maude | 2011-04-13 |
| 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 | 0 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | OBTECH MEDICAL SARL |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REALIZE ENDOSCOPIC DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2010-05-12 |
| Returned To Mfg | 2010-05-05 |
| Model Number | UNK |
| Catalog Number | RGBRS1 |
| Lot Number | ZLCBFB |
| Device Expiration Date | 2015-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBTECH MEDICAL SARL_ |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-12 |