MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-25 for UNKNOWN CLIP GUN/RANEY CLIP manufactured by Medtronic Neurosurgery.
[2145591]
It was reported to medtronic neurosurgery that a raney clip was retained in a pt. The physician recommended that medtronic add a radiographic marker to the raney clips. According to the report, a reoperations was performed for infection due to multiple risk factors, but not caused by the clip.
Patient Sequence No: 1, Text Type: D, B5
[9021822]
The product was discarded and was therefore unavailable for return. The reported event was a question concerning the radiographic visibility of the raney clip, and not related to a device malfunction. Per the report, the infection resulting in craniotomy was unrelated to the device. A review of the manufacturing records was not possible as no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2011-00081 |
| MDR Report Key | 2111722 |
| Report Source | 05,06 |
| Date Received | 2011-05-25 |
| Date of Report | 2011-03-14 |
| Date of Event | 2011-03-10 |
| Date Mfgr Received | 2011-03-14 |
| Date Added to Maude | 2011-06-06 |
| 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 | 3 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CLIP GUN/RANEY CLIP |
| Product Code | HBO |
| Date Received | 2011-05-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-05-25 |