MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-02-02 for LATERAL PERINEAL POST PAD 72200718 manufactured by Smith & Nephew, Inc..
[37336245]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37336246]
It was reported that the patient alleged to have sustained a traumatic injury resulting from a hip arthroscopy procedure conducted on (b)(6) 2015. The patient alleged to have sustained a crushing injury to her labia. This was reported more than 3 weeks after surgery. It is reported that the patient is receiving wound treatment from the orthopedic clinic as well as from her gynecologist. There are no medical reports currently available to support these allegations.
Patient Sequence No: 1, Text Type: D, B5
[54037022]
Device investigation narrative - visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product to look at. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated. Our quality department will continue to monitor for trends. No further investigation is required. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59582579]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2016-00058 |
| MDR Report Key | 5405904 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-02 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-12-23 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-02-02 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATERAL PERINEAL POST PAD |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2016-02-02 |
| Catalog Number | 72200718 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-02 |