MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-02-29 for PERINEAL PAD SUPINE 72200634 manufactured by Smith & Nephew, Inc..
[39221618]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39221619]
It was reported that the patient returned two weeks post-operatively after having a procedure in which the perineal pad was used and was showing signs of pressure sores between legs in the area where the pad would have been used.
Patient Sequence No: 1, Text Type: D, B5
[46374111]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2016-00008 |
| MDR Report Key | 5466238 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-17 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-05-31 |
| Date Added to Maude | 2016-02-29 |
| 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 | SERVICE PERSONNEL |
| 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 | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERINEAL PAD SUPINE |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2016-02-29 |
| Catalog Number | 72200634 |
| 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 | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-29 |