MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-11-17 for ERECAID ESTEEM VACUUM ERECTION SYSTEM 1135 manufactured by Timm Medical Technologies, Inc..
[21628122]
On friday october 27, 2006, a customer called claiming to have been injured while using the erecaid esteem automatic vacuum erection system. The customer stated that, while using the device to create an erection by placing the cylinder around his penis, holding it tightly against the pubic area to create a seal as designed, the vacuum created by the pump to draw blood into the penis to produce an erection drew his scrotal tissue into the system cylinder. While transferring the tension rings from the cylinder to the penis, the tension rings were applied over the scrotal sack, as well as the penis. This caused the customer considerable pain and discomfort and led the customer to seek medical treatment. The customer stated that the treating physician had to make an incision into his scrotum to repair a "split testicle". According to the customer, the physician stated that the injury was caused by either the vacuum or the tension rings of the system. Prior to this incident, the customer had been using the system 3 to 4 times a week for approximately 1 1/2 years. The customer stated that his physician has given him the ok to continue use of the device. The original device was returned by the customer for review and per the customer's request, was replaced with a new device. A review of complaint history was conducted and no same or similar incidents have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134022-2006-00001 |
| MDR Report Key | 785399 |
| Report Source | 04 |
| Date Received | 2006-11-17 |
| Date of Report | 2006-11-02 |
| Date of Event | 2006-10-07 |
| Date Mfgr Received | 2006-10-27 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-11-22 |
| 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 | 0 |
| Manufacturer Street | 6585 CITY WEST PARKWAY |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9525623931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERECAID ESTEEM VACUUM ERECTION SYSTEM |
| Generic Name | LKY |
| Product Code | LKY |
| Date Received | 2006-11-17 |
| Returned To Mfg | 2006-11-02 |
| Model Number | 1135 |
| Catalog Number | 1135 |
| Lot Number | 0000611 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 773195 |
| Manufacturer | TIMM MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | * EDEN PRAIRIE MN * US |
| Baseline Brand Name | ERECAID ESTEEM VACUUM ERECTION SYSTEM |
| Baseline Generic Name | LKY |
| Baseline Model No | 1135 |
| Baseline Catalog No | 1135 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-11-17 |