MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-16 for COMPACT WATER BATH 05.725.010 manufactured by Oberdorf Synthes Produktions Gmbh.
[133280447]
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is synthes sales rep. A review of the device history records has been requested. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[133280448]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, a compact water bath was planned to use for bending an unknown rapidsorb plate for an unknown surgery. However, the device was repeatedly operated or stopped after turning the switch on. The surgery was completed without plate bending due to surgeon's decision. It was unknown if there was surgical delay. There was no adverse consequence to the patient. Patient status was stable. Concomitant device reported: unknown rapidsorb plates (part # unknown, lot # unknown, quantity 1). This report is for one (1) compact water bath. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-59957 |
| MDR Report Key | 8253980 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-24 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2016-05-27 |
| Date Added to Maude | 2019-01-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT WATER BATH |
| Generic Name | BATH, INCUBATORS, WATER/ALL |
| Product Code | JTQ |
| Date Received | 2019-01-16 |
| Catalog Number | 05.725.010 |
| Lot Number | H098832-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-16 |