MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-20 for SONICATOR PLUS 940 ME940 manufactured by Mettler Electronics Corp..
[3454640]
On (b)(6) 2013, i received a phone call from (b)(6). She stated that a mettler me940 (s/n: (b)(4)) had allegedly caused blistering to two different patients. On (b)(6) 2013, after several failed attempts on both sides to make contact, (b)(6), contacted me and i was told that the unit was run in if mode. There were two patients. With both patients, upon completion of treatment, no wounds were apparent. Patient came back the next day with an intact blister (2nd degree burn). Patient sought no medical treatment and wound was healed within one week.
Patient Sequence No: 1, Text Type: D, B5
[10739902]
Device was evaluated by hospital bio-med and no problem was found. The device is currently being used with no further patient incidents. The device will not be returned to mettler for eval.
Patient Sequence No: 1, Text Type: N, H10
[6360832]
On (b)(6) 2013, i received a phone call from (b)(6). She stated that a mettler me940 (s/n: (b)(4)) had allegedly caused blistering to tow different patients. On (b)(6) 2013, after several failed attempts on both sides to make contact, (b)(6), contacted me and i was told that the unit was run in if mode. There were two patients. With both patients, upon completion of treatment, no wounds were apparent. Patient came back the next day with an intact blister (2nd degree burn). Patient sought no medical treatment and wound was healed within one week.
Patient Sequence No: 2, Text Type: D, B5
[14088665]
Device was evaluated by hospital bio-med and no problem was found. The device is currently being used with no further patient incidents. The device will not be returned to mettler for eval.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 2013558-2013-00004 |
| MDR Report Key | 3131365 |
| Report Source | 05 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-03-01 |
| Date Facility Aware | 2013-05-03 |
| Report Date | 2013-05-15 |
| Date Reported to FDA | 2013-05-20 |
| Date Reported to Mfgr | 2013-05-20 |
| Date Mfgr Received | 2013-05-03 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2013-05-30 |
| 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 Street | 1333 SOUTH CLAUDINA ST. |
| Manufacturer City | ANAHEIM CA 92805 |
| Manufacturer Country | US |
| Manufacturer Postal | 92805 |
| Manufacturer Phone | 7145332221 |
| Manufacturer G1 | METTLER ELECTRONICS CORP. |
| Manufacturer Street | 1333 SOUTH CLAUDINA ST. |
| Manufacturer City | ANAHEIM CA 92805 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92805 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICATOR PLUS 940 |
| Generic Name | ME940 |
| Product Code | IMG |
| Date Received | 2013-05-20 |
| Model Number | ME940 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP. |
| Manufacturer Address | 1333 SOUTH CLAUDINA ST. ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-20 |
| 2 | 0 | 2013-05-20 |