MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-11-19 for UNK V. MUELLER manufactured by Carefusion.
[4027435]
Burn. This complaint came from the independent search of the maude data base. Maude - (b)(4). Per the maude report - lighted breast retractor was placed on patient by surgeon in between uses. Staff noticed the retractor and picked it up and there was noted a superficial burn on her midline chest approximately 0. 5 inches by 1. 0 inches. Surgeon was aware. Ointment was applied. Post-op clinic visit - site noted to be healing. What was the original intended procedure - bilateral breast capsulorrhaphy and exchange of bilateral breast tissue expanders, placement of permanent bilateral silicone breast implants. Device #1 is this a laboratory device or laboratory test - no. This includes all information that was listed in the maude report. There was no customer listed, no exact product code listed. No device will be received for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[11413647]
(b)(4) - per the maude report, no device will be received for evaluation. There was no customer listed nor exact product code listed. The device was not received for evaluation and additional information was not provided. A lot number was not provided. Should the device become available, a new issue will be opened and an investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00029 |
| MDR Report Key | 3476105 |
| Report Source | * |
| Date Received | 2013-11-19 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-05-30 |
| Date Mfgr Received | 2013-11-11 |
| Date Added to Maude | 2013-11-19 |
| 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 | 0 |
| 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 | 2013-11-19 |
| Model Number | UNK V. MUELLER |
| Lot Number | UNKNOWN - NO SAMPLE WILL BE RE |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2013-11-19 |