MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2017-05-17 for TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDE 88-1086 manufactured by Carefusion, Inc.
[75369010]
(b)(4) writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[75369011]
Sales rep reported via email: customer was using our fiber optic deaver retractor and fiber optic cable this morning and a patient was burned at the connection of the retractor and cable. She did say that the retractor was set down on the patient and a burn occurred. Multiple product codes reported and captured in additional records, (b)(4). No further information available.
Patient Sequence No: 1, Text Type: D, B5
[81027260]
(b)(4): the 88-1086 tebbetts fiberoptic retractor device was not received for evaluation. The customer reported the device will not be returning under the advisement of providence health risk management team. A photo was not provided. The customer also did not communicate a lot number for the device; therefore, the dhr review could not be performed. Without the device to confirm and evaluate the reported failure, bd is unable to determine the root cause. If the device becomes available the complaint will be re-opened and a more thorough investigation will be performed. Conclusion(s): other- sample not returned. The customer did not return product for evaluation. Bd will continue to trend and monitor this reported issue and for this product family.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2017-00117 |
| MDR Report Key | 6572854 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2017-05-17 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-06-30 |
| Date Added to Maude | 2017-05-17 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDE |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2017-05-17 |
| Model Number | 88-1086 |
| Lot Number | WO115663 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-17 |