MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-01-31 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1188 manufactured by Carefusion.
[3286397]
During a surgery? A patient got a superficial skin harm caused by the contact point? Of the tebbets retractor/light cable but no medical intervention was required. However, the or nurse responsible on that date, does not remember which light retractor was used during the surgery since the hospital? Owns a carefusion device #? (b)(4) and a luxtec device #? (b)(4). The 2 cables used with? Each device is diameter 3. 5 cm referenced? Luxtec cable (b)(4). It is unclear if the tebbetts retractor was actually the device being used at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
[10490685]
As stated above the hospital owns and uses two light retractors one tebbetts retractor manufactured by carefusion ((b)(4)) and one retractor manufactured by luxtec. As the end-user is not able to confirm which product code was being used when the patient got the skin burn, no further investigation will be performed at this time. The device was not received for evaluation and additional information was not provided. A lot number was not provided, therefore, a dhr review could not be performed. Without the device, and additional information a determination could not be made. Should the device become available a new issue will be opened and an investigation will be performed and a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00002 |
| MDR Report Key | 2938392 |
| Report Source | 08 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-03 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2013-01-03 |
| Date Added to Maude | 2013-01-31 |
| 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 | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| 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 | TEBBETTS FIBEROPTIC SS RETR 15CMX30MM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2013-01-31 |
| Model Number | 88-1188 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-31 |