MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-16 for UNI-SOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.
[10063100]
Supplement 002 to provide additional information of customer reporting subsequent death: initial mdr was filed on (b)(4) 2011, and supplement report 001 containing the results of our investigation was filed on (b)(4) 2011. Upon a recent review of the complaint file and associated mdr documentation it was noted that this subsequent information regarding the patient death had not been reported in our initial supplement 001. On (b)(4) 2011, the customer contacted smith & nephew to inform us that her husband had died on or around (b)(6) 2011. Further communications with the customer's wife on (b)(6) 2011, indicated the cause of death to be cancer. As the cause of death was cancer, there will be no change to our initial investigation reported in supplement report 001 which stated the following: the customer sent in some product samples. We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. The returned sample(s) of lots 0m151, 0k209 and 0f239 as well as control samples (from stock) and other return samples of lots 0m151, 0k209 and 0f239 were analyzed by an independent test laboratory and met finished product specifications with no evidence of any objectionable or pathogenic microbial organisms found. Batch records for the lots indicate all specifications were met at the time of release and no inconsistencies were noted. An independent medical review concluded there was no correlation between the reported symptoms and the use of uni-solve wipes. No further investigation will be performed at this time.
Patient Sequence No: 1, Text Type: N, H10
[17351872]
The customer sent in some product samples. We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. The returned sample(s) of lots 0m151, 0k209 and 0f239 as well as control samples (from stock) and other return samples of lots 0m151, 0k209 and 0f239 were analyzed by an independent test laboratory and met finished product specifications with no evidence of any objectionable or pathogenic microbial organisms found. Batch records for the lots indicate all specifications were met at the time of release and no inconsistencies were noted. An independent medical review concluded there was no correlation between the reported symptoms and the use of uni-solve wipes.
Patient Sequence No: 1, Text Type: N, H10
[22127446]
This unisolve complaint was received post smith & nephew's remedial action (voluntary recall) to prevent an unreasonable risk of substantial harm to the public health (ref. Recall #3006760724-04-06-2011-001r). Patient's wife states her husband was an inpatient for 10 days. Patient's wife states her husband's symptoms: flexible temperatures, high heart rate, spasms in abdomen area and redness on her husband's belly area. Patient was diagnosed with having three bacterial infections: gram positive, gram negative and gram (unknown name).
Patient Sequence No: 1, Text Type: D, B5
[22204569]
Medical advisor's review concluded that there is no medical evidence to support any relationship between the use of unisolve wipes and this patient's symptoms. Active investigation in progress; results of investigation will be provided in a supplement report. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006760724-2011-00049 |
| MDR Report Key | 2251036 |
| Report Source | 04 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-06-03 |
| Date Mfgr Received | 2011-06-03 |
| Date Added to Maude | 2011-09-16 |
| 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 | 0 |
| Manufacturer Contact | MR TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273993785 |
| Manufacturer G1 | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Street | 970 LAKE CARILLON DRIVE SUITE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33716 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-SOLVE WIPES |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2011-09-16 |
| Model Number | 402300 |
| Lot Number | 0K209 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW WOUND MANAGEMENT |
| Manufacturer Address | 970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-09-16 |