MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-15 for OTC SINGLE HERNIA SUPPORT 2958/R-L manufactured by Surgical Appliance Industries.
[3312165]
Soft velcro panel, unbeknownst to pt at the time, cut abdomen. In an effort to continue wear and before pt sought care the pt trimmed and altered the medical device. After not healing, pt sought care at urgent care facility. Prescribed medication and wound healed.
Patient Sequence No: 1, Text Type: D, B5
[10542542]
Device was returned by pt on (b)(4) 2013. Product team analyzed product on (b)(4) 2013 and no eval could be determined due to pt trimming and altering device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1511629-2013-00001 |
| MDR Report Key | 3010968 |
| Report Source | 04 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-02-26 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2013-02-26 |
| Date Added to Maude | 2013-03-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICK STAUTBERG |
| Manufacturer Street | 3960 ROSSLYN DR. |
| Manufacturer City | CINCINNATI OH 45209 |
| Manufacturer Country | US |
| Manufacturer Postal | 45209 |
| Manufacturer Phone | 5132714594 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTC SINGLE HERNIA SUPPORT |
| Generic Name | NONE |
| Product Code | EXN |
| Date Received | 2013-03-15 |
| Returned To Mfg | 2013-02-26 |
| Model Number | 2958/R-L |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL APPLIANCE INDUSTRIES |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-15 |