MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for SUPPORT ROD ASSM-5/16 438A1188 manufactured by Integra Lifesciences Corporation Oh/usa.
[77775034]
It was reported that after the hospital sterilized the 438a1188 support rod assembly before its use and while opening the case, they found a round weld zone on the upper part of subiculum coming off. Additional information was requested and on 08jun2017, the following was reported by the customer. The product problem occurred before surgery or before patient was anesthetized. This was the first time use for the customer. Immediately after the product training was given, the product was neither disengaged nor broken. No report of patient harm or injury reported, however, the effects of surgery was reported as they had to borrow another devise set from an affiliated hospital and the surgery was delayed 120 minutes. Patient outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2017-00186 |
| MDR Report Key | 6641098 |
| Date Received | 2017-06-14 |
| Date of Report | 2017-05-29 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-06-14 |
| 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 | MS. ANNETTE ORLANDO |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPPORT ROD ASSM-5/16 |
| Generic Name | RETRACTOR SYSTEM COMPONENTS |
| Product Code | GZT |
| Date Received | 2017-06-14 |
| Returned To Mfg | 2017-06-15 |
| Catalog Number | 438A1188 |
| Lot Number | 108823/44 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 |