MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-26 for UNK V. MUELLER manufactured by Carefusion.
[20974271]
Burn.? 'a little boy was recently burned when using several different tebbetts retractors. The customer says that the light source connection has been hot at the light source and burning the drapes for about a month. They have been using a light cord that has cracks in the insulation. Customer was told to stop using any light cord that has cracks in the insulation @ that they need to use a compatible light cord which (b)(6) verified. They have been using 88-9727 - light cord 5mm, light source : luxtec, they use tebbetts retractors 88-1187, 88-1088 moving forward, they will use compatible light cord 88-9760 - 3. 5mm cable': additional information received from the sales rep (b)(4) 2014. It was reported that the customer stated that the tebbetts retractors are ok and they are just getting hot cause they were using a codd that was delivering too much energy. We will not be receiving the instruments for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[21280160]
(b)(4) should additional information be received, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2014-00037 |
| MDR Report Key | 3701353 |
| Report Source | 04 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-26 |
| Date of Event | 2014-03-04 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2014-03-26 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK V. MUELLER |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2014-03-26 |
| Model Number | UNK V. MUELLER |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-26 |