MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-03-28 for ZIMMER SE02 87 200 120 manufactured by Leonhard Lang Gmbh.
[70989789]
The customer did not return the entire involved device but sent us only the metal wire he had recovered from its surface. The piece of wire is about 40mm of length and has a diameter of 0,39mm. The investigation revealed that the wire must have been introduced inadvertently onto the gel surface in the production machine. The only conceivable source is a steel brush used at a nearby packaging machine, although the diameter of its strands appears to differ in diameter. Corrective action to prevent recurrence is being developed and will be implemented.
Patient Sequence No: 1, Text Type: N, H10
[70989790]
On (b)(6) 2017, we have been informed about an incident with zimmer stimulation electrodes. During a therapy session a patient received stimulation through a pair of stimulation electrodes. During the treatment, the patient started to feel pain. The therapist responded immediately, checked the electrodes and discovered an approximately 40 mm long metal strand. No medical intervention was necessary. Nor further details on the patient and the procedure have been disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2017-00011 |
| MDR Report Key | 6438621 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-01 |
| Device Manufacturer Date | 2017-01-30 |
| Date Added to Maude | 2017-03-28 |
| 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 | MR. BURRHUS LANG |
| Manufacturer Street | ARCHENWEG 56 6020 INNSBRUCK |
| Manufacturer City | INNSBRUCK, TIROL |
| Manufacturer Country | AU |
| Manufacturer Phone | 512 334254 |
| Manufacturer G1 | LEONHARD LANG GMBH |
| Manufacturer Street | ARCHENWEG 56 |
| Manufacturer City | INNSBRUCK, TIROL 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 6020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER |
| Generic Name | STIMULATION ELECTRODE |
| Product Code | GXY |
| Date Received | 2017-03-28 |
| Returned To Mfg | 2017-03-13 |
| Model Number | SE02 |
| Catalog Number | 87 200 120 |
| Lot Number | 70130-0641 |
| Device Expiration Date | 2019-01-31 |
| Operator | OCCUPATIONAL THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEONHARD LANG GMBH |
| Manufacturer Address | ARCHENWEG 56 INNSBRUCK, TIROL 6020 AU 6020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-28 |