MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-09-15 for UNK ENDO CLIP APPLIER * UNK ENDO C1 manufactured by North Haven - Uss.
[511987]
Reportedly, r/c: according to the patient's mother, the following allegedly occurred patient experienced an alleged local reaction to the titanium clips used on the sympathetic nerve used to treat a hyperhydrosis condition. Patient will be re-operated on in the future in order to remove those clips. Procedure: unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2006-00378 |
| MDR Report Key | 761951 |
| Report Source | 00 |
| Date Received | 2006-09-15 |
| Date of Report | 2006-09-15 |
| Date Mfgr Received | 2006-09-15 |
| Date Added to Maude | 2006-09-20 |
| 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 | 0 |
| Manufacturer Contact | JEFF DEMING |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926049 |
| Manufacturer G1 | NORTH HAVEN - USS |
| Manufacturer Street | 195 MC DERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK ENDO CLIP APPLIER |
| Generic Name | ENDO CLIP APPLIER |
| Product Code | DSS |
| Date Received | 2006-09-15 |
| Model Number | * |
| Catalog Number | UNK ENDO C1 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749842 |
| Manufacturer | NORTH HAVEN - USS |
| Manufacturer Address | 195 MCDERMOTT RD. NORTH HAVEN CT 06473 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-15 |