MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-08-08 for TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDE 88-1086 manufactured by Carefusion, Inc.
[82112162]
(b)(4). Should any additional information be obtained for this issue a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[82112163]
The customer reported, the retractor became so hot it burned the patient's skin. The failure occurred during patient use and caused patient harm, skin burn, no medical intervention and no user harm. On (b)(6) 2017 the sale rep reported, during use, when the retractor was touching skin, the skin was becoming red, the retractor was hot and the connector to the light source was hot. On (b)(6) 2017 although requested, no additional information was received from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038548-2017-00134 |
| MDR Report Key | 6774654 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-08-14 |
| Device Manufacturer Date | 2012-05-21 |
| Date Added to Maude | 2017-08-08 |
| 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 | 2017-08-08 |
| Returned To Mfg | 2017-08-01 |
| Model Number | 88-1086 |
| Lot Number | 843939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-08-08 |