MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-26 for UNK V. MUELLER manufactured by Carefusion.
[4334702]
Burn maude report # (b)(4) was received 05 march 2014. The report states: "at tebbetts lighted breast retractor was being used during breast surgery. The light source a luxtex mlx by integra was running with the light source at 100% throughout the case. The retractor was moved from the mayo stand onto the patients direct skin. An approximately 4cm burn developed inferior to the right breast, appearing light pink in color. Ointment and a wound dressing were applied to the area. During a follow-up appointment, another wound dressing was applied. The procedure was a bilateral silicone permanent breast implant with the removal of soft tissue expanders. The patient was a (b)(6) old female patient, (b)(6) with an allergy to adhesive bandage. The two tebbetts retractors that were listed were 88-1087 and 88-1088.
Patient Sequence No: 1, Text Type: D, B5
[11585069]
(b)(4). Should additional information be received, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[18767776]
(b)(4). Per email from the customer 18 (b)(6) 2014. This was a duplicate of reportable complaint (b)(4)(1038548-2013-00033). Please be informed that this complaint will be closed out in our system as a duplicate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2014-00035 |
| MDR Report Key | 3701310 |
| Report Source | 05 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-26 |
| Date of Event | 2013-12-01 |
| Date Mfgr Received | 2014-03-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |